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Key Sessions

Tony D'Amore, PhD, MBA

Examining the Advances and Challenges in Vaccine Development and Manufacture

Sanofi Pasteur

Itzcoatl Pla

Keynote: Operating in a Disruptive Bioprocessing Landscape – Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity

Bristol-Myers Squibb, USA

Showing of Streams
10:00 - 10:45

Morning Coffee & Poster Tour 1

More
Showing of Streams
12:20 - 13:30

Lunch in the Exhibition Hall and Live Labs

More
Showing of Streams
15:35 - 16:20
Info

Afternoon Coffee and Poster Tour Two

Channel One: 

Poster 4: 15:40

CRISPR/CAS9 MULTIPLEXING OF CHINESE HAMSTER OVARY B4GAL-T1, 2, 3 AND 4 TAILORS N-GLYCAN PROFILES OF MAB AND TOTAL SECRETED HOST CELL PROTEIN

Thomas Amann, Technical University of Denmark

Poster 5: 15:50

THE CHALLENGE OF EMPLOYING HIGH-THROUGHPUT METHODS FOR PROCESS CHARACTERIZATION DURING LATE STAGE DEVELOPMENT OF BIOPHARMACEUTICALS

Susanne Ulrich, Sanofi-Aventis Deutschland GmbH, Germany 

Poster 6: 16:00

A POSTER BY APPLIKON


Channel Two: 

Poster 58: 15:40

CHARACTERIZATION OF CAPTO ADHERE RESIN TO ADDRESS NEW PURIFICATION CHALLENGES FOR MONOCLONAL ANTIBODY PRODUCTION

Julia Sieben, Merck Corsier-sur-Vevey, Switzerland

Poster 59: 15:50

MAGNETIC BEAD PURIFICATION OF ANTIBODIES DIRECTLY FROM NON-CLARIFIED CELL HARVEST AT PILOT-SCALE

Nils Brechmann, PhD, KTH, Sweden

Poster 60: 16:00

ENGINEERING CHARACTERISATION OF SINGLE-USE BIOREACTORS

Ruchika Bandekar, MedImmune

More
Showing of Streams
17:20 - 17:25
End of BioProcess International Europe 2019

End of BioProcess International Europe 2019

More
08:20 - 08:30 10 mins
Cell Culture and Upstream Process Development
Chairpersons Opening Remarks
  • Margit Holzer - Scientific Director, Ulysse Consult
08:20 - 08:30 10 mins
Downstream Processing
Chairpersons Opening Remarks
  • Margit Holzer - Scientific Director, Ulysse Consult
08:20 - 08:30 10 mins
Continuous Processing
Chairpersons Opening Remarks
  • Margit Holzer - Scientific Director, Ulysse Consult
08:20 - 08:30 10 mins
Bioprocess Analytics and Control Strategies
Chairpersons Opening Remarks
  • Margit Holzer - Scientific Director, Ulysse Consult
08:20 - 08:30 10 mins
Vaccines
Chairpersons Opening Remarks
  • Margit Holzer - Scientific Director, Ulysse Consult
08:20 - 08:30 10 mins
Industry 4.0
Chairpersons Opening Remarks
  • Margit Holzer - Scientific Director, Ulysse Consult
08:20 - 08:30 10 mins
Viral Safety
Chairpersons Opening Remarks
  • Margit Holzer - Scientific Director, Ulysse Consult
08:20 - 08:30 10 mins
Cell Line Development & Engineering
Chairpersons Opening Remarks
08:30 - 09:00 30 mins
Info
Cell Culture and Upstream Process Development
Examining the Advances and Challenges in Vaccine Development and Manufacture
  • Tony D'Amore, PhD, MBA - Vice President, Product Research and Development, Sanofi Pasteur

This presentation will review the constraints and complexities of vaccine product development and manufacture.  With this increasing complexity, higher costs and competition; evolutions in bioprocess and analytical technologies to accelerate and overcome these challenges are reviewed.  Strategies to leverage innovation and technology for rapid product development and increasing productivity are discussed.  Specific examples are provided, as well as emerging technologies, such as continuous manufacture.

08:30 - 09:00 30 mins
Info
Downstream Processing
Examining the Advances and Challenges in Vaccine Development and Manufacture
  • Tony D'Amore, PhD, MBA - Vice President, Product Research and Development, Sanofi Pasteur

This presentation will review the constraints and complexities of vaccine product development and manufacture.  With this increasing complexity, higher costs and competition; evolutions in bioprocess and analytical technologies to accelerate and overcome these challenges are reviewed.  Strategies to leverage innovation and technology for rapid product development and increasing productivity are discussed.  Specific examples are provided, as well as emerging technologies, such as continuous manufacture.

08:30 - 09:00 30 mins
Info
Continuous Processing
Examining the Advances and Challenges in Vaccine Development and Manufacture
  • Tony D'Amore, PhD, MBA - Vice President, Product Research and Development, Sanofi Pasteur

This presentation will review the constraints and complexities of vaccine product development and manufacture.  With this increasing complexity, higher costs and competition; evolutions in bioprocess and analytical technologies to accelerate and overcome these challenges are reviewed.  Strategies to leverage innovation and technology for rapid product development and increasing productivity are discussed.  Specific examples are provided, as well as emerging technologies, such as continuous manufacture.

08:30 - 09:00 30 mins
Info
Bioprocess Analytics and Control Strategies
Examining the Advances and Challenges in Vaccine Development and Manufacture
  • Tony D'Amore, PhD, MBA - Vice President, Product Research and Development, Sanofi Pasteur

This presentation will review the constraints and complexities of vaccine product development and manufacture.  With this increasing complexity, higher costs and competition; evolutions in bioprocess and analytical technologies to accelerate and overcome these challenges are reviewed.  Strategies to leverage innovation and technology for rapid product development and increasing productivity are discussed.  Specific examples are provided, as well as emerging technologies, such as continuous manufacture.

08:30 - 09:00 30 mins
Info
Vaccines
Examining the Advances and Challenges in Vaccine Development and Manufacture
  • Tony D'Amore, PhD, MBA - Vice President, Product Research and Development, Sanofi Pasteur

This presentation will review the constraints and complexities of vaccine product development and manufacture.  With this increasing complexity, higher costs and competition; evolutions in bioprocess and analytical technologies to accelerate and overcome these challenges are reviewed.  Strategies to leverage innovation and technology for rapid product development and increasing productivity are discussed.  Specific examples are provided, as well as emerging technologies, such as continuous manufacture.

08:30 - 09:00 30 mins
Info
Industry 4.0
Examining the Advances and Challenges in Vaccine Development and Manufacture
  • Tony D'Amore, PhD, MBA - Vice President, Product Research and Development, Sanofi Pasteur

This presentation will review the constraints and complexities of vaccine product development and manufacture.  With this increasing complexity, higher costs and competition; evolutions in bioprocess and analytical technologies to accelerate and overcome these challenges are reviewed.  Strategies to leverage innovation and technology for rapid product development and increasing productivity are discussed.  Specific examples are provided, as well as emerging technologies, such as continuous manufacture.

08:30 - 09:00 30 mins
Info
Viral Safety
Examining the Advances and Challenges in Vaccine Development and Manufacture
  • Tony D'Amore, PhD, MBA - Vice President, Product Research and Development, Sanofi Pasteur

This presentation will review the constraints and complexities of vaccine product development and manufacture.  With this increasing complexity, higher costs and competition; evolutions in bioprocess and analytical technologies to accelerate and overcome these challenges are reviewed.  Strategies to leverage innovation and technology for rapid product development and increasing productivity are discussed.  Specific examples are provided, as well as emerging technologies, such as continuous manufacture.

08:30 - 09:00 30 mins
Info
Cell Line Development & Engineering
Genome Scale Science For CHO: From Chasing The High Productivity Miracle Gene To Exquisite Phenotype Control
  • Nicole Borth - Professor, BOKU University and ACIB

Traditionally in cell line development and engineering, there was a quest for individual genes which, if overexpressed or knocked out, would enhance performance, with very limited success. However, high level performance is more likely to be the result of the perfect combination of expression level of multiple genes. Today, with detailed knowledge of genomes, transcriptomes and the regulatory mechanisms that define the later, and with new tools available to manipulate these, the exquisite control of phenotypes starts to become a realistic target.

09:00 - 09:30 30 mins
Cell Culture and Upstream Process Development
Keynote: Operating in a Disruptive Bioprocessing Landscape – Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Itzcoatl Pla - Head of Global MS&T Capabilities, Bristol-Myers Squibb, USA
09:00 - 09:30 30 mins
Downstream Processing
Keynote: Operating in a Disruptive Bioprocessing Landscape – Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Itzcoatl Pla - Head of Global MS&T Capabilities, Bristol-Myers Squibb, USA
09:00 - 09:30 30 mins
Continuous Processing
Keynote: Operating in a Disruptive Bioprocessing Landscape – Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Itzcoatl Pla - Head of Global MS&T Capabilities, Bristol-Myers Squibb, USA
09:00 - 09:30 30 mins
Bioprocess Analytics and Control Strategies
Keynote: Operating in a Disruptive Bioprocessing Landscape – Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Itzcoatl Pla - Head of Global MS&T Capabilities, Bristol-Myers Squibb, USA
09:00 - 09:30 30 mins
Vaccines
Keynote: Operating in a Disruptive Bioprocessing Landscape – Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Itzcoatl Pla - Head of Global MS&T Capabilities, Bristol-Myers Squibb, USA
09:00 - 09:30 30 mins
Industry 4.0
Keynote: Operating in a Disruptive Bioprocessing Landscape – Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Itzcoatl Pla - Head of Global MS&T Capabilities, Bristol-Myers Squibb, USA
09:00 - 09:30 30 mins
Viral Safety
Keynote: Operating in a Disruptive Bioprocessing Landscape – Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Itzcoatl Pla - Head of Global MS&T Capabilities, Bristol-Myers Squibb, USA
09:00 - 09:30 30 mins
Info
Cell Line Development & Engineering
Technology Toolbox for Cell Line Development
  • Holger Laux - Fellow, Novartis Cell Line Development

Chinese Hamster Ovary cells are widely used for large-scale production of recombinant biopharmaceuticals. We will present that applying transcriptomics derived approaches supported the identification of the root cause of cell growth inhibition and low productivity of a difficult to express therapeutic protein and how state of the art cell line engineering tools enabled the high expression of this therapeutic protein. Especially the combination of the recently published CHO genome with screening methods and cell line engineering tools has enabled the development of superior CHO cell lines.

09:30 - 10:00 30 mins
Info
Cell Culture and Upstream Process Development
Opportunities to Optimize Data Management in the Biologics Development Lifecycle
  • Unjulie Bhanot - Solutions Consultant, IDBS

Join us in this session, when we explore how an effective bioprocess solution can support your organization in transforming operations across the biologics development lifecycle to enable better scientific and business insight, including

  • Common data management pain points in the biologics development space
  • the impact of ineffective data management, and
  • the junctures at which to break down existing barriers,

As those within the biologics development industry pursue their goal to deliver novel, high quality therapeutics to patients faster and more cost effectively, there is a stronger, more imperative need to bring together data from the science, technology and business operations. 

Managing that data is complicated by the existence of different groups, sites, and external partners that make up the ecosystem responsible for developing and manufacturing a new biologic.

To further compound the problem, the biologics development industry is subjected to a growing set of data integrity regulations and approval policies, as well as increases in operational costs. As a result, organizations often generate vast amounts of high-value scientific and process data which may not be standardized and is usually stored in disparate locations and unconnected systems.

Biologics development data will also go through a lifecycle of its own - from collecting and integrating, to processing and analyzing, leading to the requirement to either share or store it – and usually both. Extrapolate that across the ecosystem and it becomes apparent there are numerous opportunities at which biologics data management can be optimized and implemented more proficiently.

Wouldn’t really have a “technology” arm of the business so I’m a bit hesitant to write that. Maybe data from the science…and business operations?

09:30 - 10:00 30 mins
Info
Downstream Processing
Opportunities to Optimize Data Management in the Biologics Development Lifecycle
  • Unjulie Bhanot - Solutions Consultant, IDBS

Join us in this session, when we explore how an effective bioprocess solution can support your organization in transforming operations across the biologics development lifecycle to enable better scientific and business insight, including

  • Common data management pain points in the biologics development space
  • the impact of ineffective data management, and
  • the junctures at which to break down existing barriers,

As those within the biologics development industry pursue their goal to deliver novel, high quality therapeutics to patients faster and more cost effectively, there is a stronger, more imperative need to bring together data from the science, technology and business operations. 

Managing that data is complicated by the existence of different groups, sites, and external partners that make up the ecosystem responsible for developing and manufacturing a new biologic.

To further compound the problem, the biologics development industry is subjected to a growing set of data integrity regulations and approval policies, as well as increases in operational costs. As a result, organizations often generate vast amounts of high-value scientific and process data which may not be standardized and is usually stored in disparate locations and unconnected systems.

Biologics development data will also go through a lifecycle of its own - from collecting and integrating, to processing and analyzing, leading to the requirement to either share or store it – and usually both. Extrapolate that across the ecosystem and it becomes apparent there are numerous opportunities at which biologics data management can be optimized and implemented more proficiently.

Wouldn’t really have a “technology” arm of the business so I’m a bit hesitant to write that. Maybe data from the science…and business operations?

09:30 - 10:00 30 mins
Info
Continuous Processing
Opportunities to Optimize Data Management in the Biologics Development Lifecycle
  • Unjulie Bhanot - Solutions Consultant, IDBS

Join us in this session, when we explore how an effective bioprocess solution can support your organization in transforming operations across the biologics development lifecycle to enable better scientific and business insight, including

  • Common data management pain points in the biologics development space
  • the impact of ineffective data management, and
  • the junctures at which to break down existing barriers,

As those within the biologics development industry pursue their goal to deliver novel, high quality therapeutics to patients faster and more cost effectively, there is a stronger, more imperative need to bring together data from the science, technology and business operations. 

Managing that data is complicated by the existence of different groups, sites, and external partners that make up the ecosystem responsible for developing and manufacturing a new biologic.

To further compound the problem, the biologics development industry is subjected to a growing set of data integrity regulations and approval policies, as well as increases in operational costs. As a result, organizations often generate vast amounts of high-value scientific and process data which may not be standardized and is usually stored in disparate locations and unconnected systems.

Biologics development data will also go through a lifecycle of its own - from collecting and integrating, to processing and analyzing, leading to the requirement to either share or store it – and usually both. Extrapolate that across the ecosystem and it becomes apparent there are numerous opportunities at which biologics data management can be optimized and implemented more proficiently.

Wouldn’t really have a “technology” arm of the business so I’m a bit hesitant to write that. Maybe data from the science…and business operations?

09:30 - 10:00 30 mins
Info
Bioprocess Analytics and Control Strategies
Opportunities to Optimize Data Management in the Biologics Development Lifecycle
  • Unjulie Bhanot - Solutions Consultant, IDBS

Join us in this session, when we explore how an effective bioprocess solution can support your organization in transforming operations across the biologics development lifecycle to enable better scientific and business insight, including

  • Common data management pain points in the biologics development space
  • the impact of ineffective data management, and
  • the junctures at which to break down existing barriers,

As those within the biologics development industry pursue their goal to deliver novel, high quality therapeutics to patients faster and more cost effectively, there is a stronger, more imperative need to bring together data from the science, technology and business operations. 

Managing that data is complicated by the existence of different groups, sites, and external partners that make up the ecosystem responsible for developing and manufacturing a new biologic.

To further compound the problem, the biologics development industry is subjected to a growing set of data integrity regulations and approval policies, as well as increases in operational costs. As a result, organizations often generate vast amounts of high-value scientific and process data which may not be standardized and is usually stored in disparate locations and unconnected systems.

Biologics development data will also go through a lifecycle of its own - from collecting and integrating, to processing and analyzing, leading to the requirement to either share or store it – and usually both. Extrapolate that across the ecosystem and it becomes apparent there are numerous opportunities at which biologics data management can be optimized and implemented more proficiently.

Wouldn’t really have a “technology” arm of the business so I’m a bit hesitant to write that. Maybe data from the science…and business operations?

09:30 - 10:00 30 mins
Info
Vaccines
Opportunities to Optimize Data Management in the Biologics Development Lifecycle
  • Unjulie Bhanot - Solutions Consultant, IDBS

Join us in this session, when we explore how an effective bioprocess solution can support your organization in transforming operations across the biologics development lifecycle to enable better scientific and business insight, including

  • Common data management pain points in the biologics development space
  • the impact of ineffective data management, and
  • the junctures at which to break down existing barriers,

As those within the biologics development industry pursue their goal to deliver novel, high quality therapeutics to patients faster and more cost effectively, there is a stronger, more imperative need to bring together data from the science, technology and business operations. 

Managing that data is complicated by the existence of different groups, sites, and external partners that make up the ecosystem responsible for developing and manufacturing a new biologic.

To further compound the problem, the biologics development industry is subjected to a growing set of data integrity regulations and approval policies, as well as increases in operational costs. As a result, organizations often generate vast amounts of high-value scientific and process data which may not be standardized and is usually stored in disparate locations and unconnected systems.

Biologics development data will also go through a lifecycle of its own - from collecting and integrating, to processing and analyzing, leading to the requirement to either share or store it – and usually both. Extrapolate that across the ecosystem and it becomes apparent there are numerous opportunities at which biologics data management can be optimized and implemented more proficiently.

Wouldn’t really have a “technology” arm of the business so I’m a bit hesitant to write that. Maybe data from the science…and business operations?

09:30 - 10:00 30 mins
Info
Industry 4.0
Opportunities to Optimize Data Management in the Biologics Development Lifecycle
  • Unjulie Bhanot - Solutions Consultant, IDBS

Join us in this session, when we explore how an effective bioprocess solution can support your organization in transforming operations across the biologics development lifecycle to enable better scientific and business insight, including

  • Common data management pain points in the biologics development space
  • the impact of ineffective data management, and
  • the junctures at which to break down existing barriers,

As those within the biologics development industry pursue their goal to deliver novel, high quality therapeutics to patients faster and more cost effectively, there is a stronger, more imperative need to bring together data from the science, technology and business operations. 

Managing that data is complicated by the existence of different groups, sites, and external partners that make up the ecosystem responsible for developing and manufacturing a new biologic.

To further compound the problem, the biologics development industry is subjected to a growing set of data integrity regulations and approval policies, as well as increases in operational costs. As a result, organizations often generate vast amounts of high-value scientific and process data which may not be standardized and is usually stored in disparate locations and unconnected systems.

Biologics development data will also go through a lifecycle of its own - from collecting and integrating, to processing and analyzing, leading to the requirement to either share or store it – and usually both. Extrapolate that across the ecosystem and it becomes apparent there are numerous opportunities at which biologics data management can be optimized and implemented more proficiently.

Wouldn’t really have a “technology” arm of the business so I’m a bit hesitant to write that. Maybe data from the science…and business operations?

09:30 - 10:00 30 mins
Info
Viral Safety
Challenges of implementing virus filtration in continuous manufacturing
  • Sebastian B. Teitz - Product Manager & Scientific Coordinator, Asahi Kasei Bioprocess Europe

Continuous processing may transform manufacturing of biotherapeutics through improvements to cost and quality. As a flow-through operation, virus filtration (VF) seems adaptable to this paradigm, but impacts of dynamic conditions on viral clearance & performance of VFs is being investigated. Continuous VF operations require new approaches to viral clearance validation and this presentation explores its design and illustrates the impacts of potential continuous process conditions on viral clearance.

09:30 - 10:00 30 mins
Info
Cell Line Development & Engineering
CRISPR screening to improve the CHO cell host: Getting involved in the creation of the next-generation CHO line
  • Mario Pereira - Field Application Scientist, Horizon Discovery

Horizon Discovery has optimised cell-based assays which will be combined with our expertise in CRISPR screening to identify novel genetic targets that will improve the CHO cell host for biomanufacturing. We will describe the outcomes of our proof of concept work and how we intend to partner with companies interested in being at the forefront of innovation in this field.

10:00 - 10:45 45 mins
Morning Coffee & Poster Tour 1
10:45 - 10:50 5 mins
Cell Culture and Upstream Process Development
Chairperson's Opening Remarks
  • Jurgen Van de Lagemaat - Senior Principal Scientist, MSD, The Netherlands
10:45 - 10:50 5 mins
Downstream Processing
Chairperson's Opening Remarks
  • Michel Eppink - Director Downstream Processing, Synthon Biopharmaceuticals BV, The Netherlands
10:45 - 10:50 5 mins
Continuous Processing
Chairperson's Opening Remarks
10:45 - 10:50 5 mins
Bioprocess Analytics and Control Strategies
Chairperson's Opening Remarks
10:45 - 10:50 5 mins
Vaccines
Chairperson's Opening Remarks
  • Dr. A. Krishna Prasad, Ph.D. - Founder, Citranvi, LLC.
10:45 - 10:50 5 mins
Industry 4.0
Chairperson's Opening Remarks
10:45 - 10:50 5 mins
Viral Safety
Chairperson's Opening Remarks
  • Aaron Mack - Engineer III, Biogen
10:50 - 11:20 30 mins
Info
Cell Culture and Upstream Process Development
How Can We Reflect The Dynamic Nature Of Process Operation In The Design Space Representation?
  • Moritz Von Stosch - Senior Manager, Process Systems Biology and Engineering Centre of Excellence, GlaxoSmithKline

Regulators seem to accept manifold ways of defining and representing the design space. However, the large majority of design spaces described in publications seems to follow a “static” statistical experimentation and modeling approach. Given that temporal deviations in the process parameters (i.e. moving within the design space) are of dynamic nature, static approaches might/do not suffice for the consideration of such deviations.

In this contribution, different and alternative forms of design space representations are shown and the limitations of the current predominantly applied static approach are shown. The need for a representation of the process dynamics and their characterization for the design space definition are discussed. Approaches for the representation and characterization of the process dynamics are proposed. Finally, it is highlighted that these approaches might create an opportunity to integrate the activities of process characterization, process monitoring and process control strategy development, as defined in the Quality by Design workflow.

10:50 - 11:20 30 mins
Downstream Processing
Single Use Technologies within Biopharmaceutical Processing
  • Michel Eppink - Director Downstream Processing, Synthon Biopharmaceuticals BV, The Netherlands
10:50 - 11:20 30 mins
Continuous Processing
Constitutive Cell Lines for Lentivirus Production: Tools for Continuous Up- and Downstream Processing
  • Manuel Carrondo - Professor of Chemical and Biochemical Engineering, FCT-UNL Vice-President, iBET Portugal
10:50 - 11:20 30 mins
Info
Bioprocess Analytics and Control Strategies
How Can We Reflect The Dynamic Nature Of Process Operation In The Design Space Representation?
  • Moritz Von Stosch - Senior Manager, Process Systems Biology and Engineering Centre of Excellence, GlaxoSmithKline

Regulators seem to accept manifold ways of defining and representing the design space. However, the large majority of design spaces described in publications seems to follow a “static” statistical experimentation and modeling approach. Given that temporal deviations in the process parameters (i.e. moving within the design space) are of dynamic nature, static approaches might/do not suffice for the consideration of such deviations.

In this contribution, different and alternative forms of design space representations are shown and the limitations of the current predominantly applied static approach are shown. The need for a representation of the process dynamics and their characterization for the design space definition are discussed. Approaches for the representation and characterization of the process dynamics are proposed. Finally, it is highlighted that these approaches might create an opportunity to integrate the activities of process characterization, process monitoring and process control strategy development, as defined in the Quality by Design workflow.

10:50 - 11:20 30 mins
Info
Vaccines
How Can We Reflect The Dynamic Nature Of Process Operation In The Design Space Representation?
  • Moritz Von Stosch - Senior Manager, Process Systems Biology and Engineering Centre of Excellence, GlaxoSmithKline

Regulators seem to accept manifold ways of defining and representing the design space. However, the large majority of design spaces described in publications seems to follow a “static” statistical experimentation and modeling approach. Given that temporal deviations in the process parameters (i.e. moving within the design space) are of dynamic nature, static approaches might/do not suffice for the consideration of such deviations.

In this contribution, different and alternative forms of design space representations are shown and the limitations of the current predominantly applied static approach are shown. The need for a representation of the process dynamics and their characterization for the design space definition are discussed. Approaches for the representation and characterization of the process dynamics are proposed. Finally, it is highlighted that these approaches might create an opportunity to integrate the activities of process characterization, process monitoring and process control strategy development, as defined in the Quality by Design workflow.

10:50 - 11:20 30 mins
Info
Industry 4.0
How Can We Reflect The Dynamic Nature Of Process Operation In The Design Space Representation?
  • Moritz Von Stosch - Senior Manager, Process Systems Biology and Engineering Centre of Excellence, GlaxoSmithKline

Regulators seem to accept manifold ways of defining and representing the design space. However, the large majority of design spaces described in publications seems to follow a “static” statistical experimentation and modeling approach. Given that temporal deviations in the process parameters (i.e. moving within the design space) are of dynamic nature, static approaches might/do not suffice for the consideration of such deviations.

In this contribution, different and alternative forms of design space representations are shown and the limitations of the current predominantly applied static approach are shown. The need for a representation of the process dynamics and their characterization for the design space definition are discussed. Approaches for the representation and characterization of the process dynamics are proposed. Finally, it is highlighted that these approaches might create an opportunity to integrate the activities of process characterization, process monitoring and process control strategy development, as defined in the Quality by Design workflow.

10:50 - 11:20 30 mins
Viral Safety
A Regulatory Perspective on Using Next Generation Sequencing for Adventitious Virus Detection
  • Arifa Khan - Supervisory Microbiologist, FDA
10:50 - 11:20 30 mins
Info
Cell Line Development & Engineering
Characterizing Clone Performance: A Union of Structure and Sequencing
  • Steven Huhn - Senior Scientist, MSD

Chinese hamster ovary (CHO) cells are a common tool utilized in bioproduction and directed genome engineering of CHO cells is of great interest in order to generate robust recombinant cell lines. Until recently, this focus has been challenged by the lack of flexible, high throughput gene editing modalities, high throughput screening methods, and a complete CHO genome assembly. In this work, we utilize next-generation sequencing in conjunction with CRISPR Cas9 RNPs perform genome editing targeted at the active site of the glutamine synthetase (GS) gene. We demonstrate that in vitro generated Cas9 RNP complexes containing synthetic gRNA achieved site-specific gene editing of >80% in CHO cells without selection. Furthermore, CRISPR RNPs demonstrate no effects on cell viability and growth, in contrast to harsh cytotoxicity associated with Zinc Finger Nuclease (ZFN) mRNAs. In addition, we describe how Cas9 yields a unique spectrum of mutations distinct from ZFN mediated approaches. Last, we show how CRISPR and ZFN technologies can be applied in conjunction with the TIDE (Tracking of Indels by Decomposition) algorithm in order to identify edited clonal cell populations in as little as one day, leading to high throughput screening and identification of CHO clones.

11:20 - 11:50 30 mins
Info
Cell Culture and Upstream Process Development
Scale-down cell culture models for process characterization in vaccine manufacturing
  • Ilse Remmers - Scientist USP, Janssen Vaccines & Prevention

Janssen Vaccines uses a perfusion-based PER.C6® cell culture process for Adenovirus vaccine production. This process has been successfully used to produce early phase clinical trial material for various vaccine development programs and is now moving on towards late stage development. To support elaborate process characterization studies, a representative reduced scale model is needed. In this presentation we highlight our approach and challenges towards scaling-down our full scale high-cell density perfusion process.

11:20 - 11:50 30 mins
Downstream Processing
Depth Filtration Vs. Single Use Centrifugation for Developing a 2nd Generation Commercial Manufacturing Process
  • Daniel Fleischanderl - Head, Upstream Process Development, Shire
11:20 - 11:50 30 mins
Continuous Processing
Continuous Processes for Glyco-Optimized or Difficult-to-Express Proteins
  • Vicky Goralczyk, Ph.D - Director, Cell Line and Bioprocess Development, Glycotope GmbH
11:20 - 11:50 30 mins
Info
Bioprocess Analytics and Control Strategies
Advancing Downstream Process Development Through Data Analyses and In-Silico Models
  • Dr Alexander Wiedenmann - Associate Director Protein Science and lab head, Boehringer Ingelheim

Boehringer-Ingelheim will present its state-of-the-art approach for rapid downstream development of robust processes that are fit for commercial manufacturing. The BI development platform delivers reliably robust and highly productive processes for IgGs and novel mAb formats. The platform is being complemented by techniques like Kp screening and smart DoE designs to quickly identify optimal purification conditions and characterize the available design space early on. Additionally, the in-depth analysis of development data and the in-silico modelling of processes provides valuable process knowledge, facilitates late stage activities and further optimize the process transfer to our commercial facilities for the manufacturing of biopharmaceutical products.

11:20 - 11:50 30 mins
Info
Vaccines
Scale-down cell culture models for process characterization in vaccine manufacturing
  • Ilse Remmers - Scientist USP, Janssen Vaccines & Prevention

Janssen Vaccines uses a perfusion-based PER.C6® cell culture process for Adenovirus vaccine production. This process has been successfully used to produce early phase clinical trial material for various vaccine development programs and is now moving on towards late stage development. To support elaborate process characterization studies, a representative reduced scale model is needed. In this presentation we highlight our approach and challenges towards scaling-down our full scale high-cell density perfusion process.

11:20 - 11:50 30 mins
Info
Industry 4.0
Advancing Downstream Process Development Through Data Analyses and In-Silico Models
  • Dr Alexander Wiedenmann - Associate Director Protein Science and lab head, Boehringer Ingelheim

Boehringer-Ingelheim will present its state-of-the-art approach for rapid downstream development of robust processes that are fit for commercial manufacturing. The BI development platform delivers reliably robust and highly productive processes for IgGs and novel mAb formats. The platform is being complemented by techniques like Kp screening and smart DoE designs to quickly identify optimal purification conditions and characterize the available design space early on. Additionally, the in-depth analysis of development data and the in-silico modelling of processes provides valuable process knowledge, facilitates late stage activities and further optimize the process transfer to our commercial facilities for the manufacturing of biopharmaceutical products.

11:20 - 11:50 30 mins
Viral Safety
Testing strategies for adventitious agents: impact of NGS introduction
  • Laurent Mallet - Global Head, Analytical Sciences, Sanofi Pasteur, France
11:20 - 11:50 30 mins
Info
Cell Line Development & Engineering
Engineering Strategies to Suppress Viral Particle Release from CHO Cells
  • Nicolas Mermod, Ph.D. - Professor, Director, Institute of Biotechnology, University of Lausanne, Switzerland

CHO cells are known to express endogenous viral elements embedded in their genome, and to release retroviral-like particles in the culture supernatant. This complicates the detection of potential contamination by viral adventitious agents, and, despite the lack of evidence of infectivity of these particles, raises safety and regulatory concerns. Using Next generation sequencing approaches, we characterized several families of endogenous retroviral elements (ERVs) present in CHO-K1 cell genome. We focused on one highly conserved ERV group of the Gammaretrovirus gender, as it was potentially functional. Transcriptome and viral particle analysis validated the functionality of ERVs from this group, and it further indicated that the mRNA and viral genome may be expressed from few (approximately 3) ERV sequences. Using CRISPR-Cas9-mediated CHO genome engineering, we mutagenized the conserved ERV sequence group. Comparison of genomic and viral particle sequences allowed the identification of one ERV that encodes the viral genome of corresponding retroviral particles. We show that particular mutations within this ERV suffice to decrease the release of viral genome-loaded particles below detection limits.

11:50 - 12:20 30 mins
Cell Culture and Upstream Process Development
Process Optimization of a Platform Manufacturing Process
  • Tim Revett - Associate Principal Scientist, Lonza
11:50 - 12:20 30 mins
Info
Downstream Processing
Development of a novel fiber-based chromatography platform to break downstream bottlenecks
  • Linnea Troeng - Product Manager, BioProcess Downstream Resin, GE Healthcare

There is a growing need for new purification technologies that offer a greater flexibility to meet broader bioprocessing needs from early process development right through to large-scale commercial production. Personalized medicines and smaller patient populations drives demand for quick process development workflows, process efficiency, flexibility, and multiproduct facilities.

In this presentation we describe the development of a novel cellulose fiber-based chromatography solution called Fibro. The technology combines high binding capacity with high flow rates to enable increased productivity from process development to clinical and commercial mAb purification. Fibro technology is suitable for increasing productivity of traditional batch processing. Its flexibility also facilitates connected processing workflows and allows productivity of mAb capture at levels beyond those currently obtained with continuous chromatography. As this technology nears commercial launch, we discuss the opportunities with Fibro chromatography in relation to current and future downstream bioprocess solutions.

11:50 - 12:20 30 mins
Info
Continuous Processing
Enhanced process flexibility and process consistency by continuous downstream processing
  • Marc Bisschops - Director SLS Continuous Processing, Pall Biotech

Over the past few years, the field of continuous bioprocessing has evolved rapidly. It has often been stated that continuous bioprocessing provides significant opportunities for cost reduction in downstream processing, both at clinical scale and in routine manufacturing of biopharmaceutical products.

One of the biggest values of continuous bioprocessing, however, could well be the tremendous process flexibility if offers, while maintaining process consistency. In traditional batch downstream processing, variabilities in the process automatically affect the consistency in – for instance – column loading and other process attributes. Continuous downstream processing offers opportunities to run at much more consistent conditions, providing more consistent product quality.

11:50 - 12:20 30 mins
Bioprocess Analytics and Control Strategies
Spotlight Presentation
11:50 - 12:20 30 mins
Info
Vaccines
Reduce Time to Clinic with High Throughput Process Development Solutions for Viral Vector Purification
  • Jean-Marc Cappia - Head of Segment Marketing Vaccines, Sartorius Stedim Biotech
  • Carole Langlois - Marketing Manager-Traditional Vaccines, Sartorius Stedim Biotech FMT SAS

Viral vectors have become one of the most rapidly evolving and promising fields in vaccinology and regenerative medicine. The Downstream Process is challenging to develop because each vector has its own properties. There is not one-fit-all solution. How then should process development scientists approach the development of a viral vector downstream processing, knowing that each process is unique?

This presentation will give you an overview of the Sartorius approach to accelerate the development of Downstream Processing, combining our well proven technologies – such as membrane chromatography and tangential flow filtration – with state-of-the art automated systems and Design of Experiment Software.

The presentation will include an introduction to the first ambr® system applied to Downstream Processing. ambr® crossflow is a benchtop system optimised for ultrafiltration and diafiltration applications, capable of performing up to 16 trials in parallel.

11:50 - 12:20 30 mins
Industry 4.0
Spotlight Presentation
11:50 - 12:20 30 mins
Info
Viral Safety
Adventitious Virus Detection in Cells by High-Throughput Sequencing (HTS) of Newly Synthetized RNAs: Unambiguous Differentiation of Cell Infection from Carryover of Viral Nucleic Acids
  • Marc Eloit - Scientific Advisor, Professor at Institut Pasteur, Pathogen Discovery Lab, PathoQuest
  • Jean-Pol Cassart - Director - Viral Safety, Vaccines Global Analytical Science and Technology, GSK Vaccines

The use of High Throughput Sequencing to identify viruses in biologicals differs from current molecular approaches since its use enables an unbiased approach to detection without the need to design specific primers to preamplify target sequences. Its broad range of detection and analytical sensitivity make it an important tool to insure biologicals are free from viruses. Similar to other molecular methods, however, identification of viral sequences in cells by HTS does not prove cell infection since this could reflect carryover of inert viral sequences from reagents or other sources. Due to the broad range of detection associated with HTS, the above can be potentially perceived as a drawback for the testing of pharmaceutical biological. In order to avoid the identification of inert viral sequences, we present a methodology based on metabolic RNA labelling and sequencing which enables the specific identification of newly synthetized viral RNAs in infected cells resulting in the ability to unambiguously distinguish cellular infection by DNA or RNA viruses from carryover of inert nucleic acids. In the present study we report as a proof of concept the ability to differentiate Vero cells acutely infected by a single-stranded positive RNA virus (Tick Borne Encephalitis Virus) from cells which have been in contact with non-replicating virus particles. Additionally, we also found an unexpected Squirrel Monkey retrovirus in our Vero cell line.

In addition to testing of cells for adventitious virus, the method has very broad applications because it can be used each time cell infection must be detected in a background of inert viral sequences: read-out of virus bioassays for raw materials like Bovine Serum, testing for vaccine inactivation, searching for revertants in replication-defective virus stocks. It can also be extended to the bacterial world (testing for mycoplasma).

11:50 - 12:05 15 mins
Info
Cell Line Development & Engineering
Addressing Large-Scale Manufacturing of Clinical Grade Viral Vectors Using an Optimized PEI-based Transfection Process
  • Dr Alengo Nyamay’antu - Scientific Support & Communication Specialist, Polyplus-transfection

With the progress in developing new viral vector systems guided by safety, specificity and potency considerations, several gene and cell-based therapies are now more than ever closer to being clinically approved and commercially available to treat genetic diseases.

Viral vector delivery systems, of which mainly adeno-associated viruses (AAV) and lentiviruses are produced by transient transfection of mammalian producer HEK-293 cell lines. Virus vector production using the right transient transfection method is crucial to provide the flexibility and reproducibility that is needed to scale-up from initial process development to manufacturing of high-quality grade viral vectors.

Here, we describe an optimized PEI-based virus production process for high-yielding viral vector production, compatible with different cell culture adherent and suspension systems. We further demonstrate the robust viral vector production yields, as well as the adaptability and reliability of the PEI-based transient gene expression approach to efficiently manufacture GMP-grade viral vectors at a sufficiently large scale for more advanced clinical trials, and in fine to drive commercialization of therapeutic vectors.

12:05 - 12:20 15 mins
Info
Cell Line Development & Engineering
Whole-genome sequencing-based methods to characterize cell lines used for therapeutic protein production and to determine clonality
  • Alexandre Kuhn, PhD - Director, Whole-Genome Sequencin, Selexis

Next-generation sequencing (NGS) and other novel genomic techniques represent unprecedented opportunities to improve the genetic characterization of cell lines used for therapeutic protein production. Over the past years, we have developed and validated NGS-based methods to identify integration sites, copy number and integrity of the expression construct in CHO cell lines. Recently, we have introduced a new, formal statistical test of clonality based on the fixation of single nucleotide variant mutations. We will present two approaches for direct, genomic assessment of clonality in conditions typical of cell line development and we will show how they can provide new levels of safety and efficiency for biotechnological therapeutic protein production.

12:20 - 13:30 70 mins
Lunch in the Exhibition Hall and Live Labs
13:30 - 13:35 5 mins
Vaccines
Chairperson's Opening Remarks
  • Manuel Carrondo - Professor of Chemical and Biochemical Engineering, FCT-UNL Vice-President, iBET Portugal
13:35 - 14:05 30 mins
Info
Cell Culture and Upstream Process Development
Small Scale Bioprocess Optimization Using Soft Sensors
  • Rüdiger Maschke - Research Scientist, Zurich University of Applied Sciences

The development and optimization of cell and microbial cultures is usually done in small scale vessel like shake flasks. However, these vessels lack the sensors and hence information provided by larger bioreactors like biomass concentration, oxygen saturation and pH-values. The proposed presentation will show approaches to overcome these hurdles for mammalian (CHO), animal (insect cells: Sf9) and plant cell cultures as well as microbial fermentations. The first part covers measurement improvements for shake flasks with focus on back-scattered light for biomass growth monitoring and the utilization of sensor spots for a deeper insight into the “black box” shake flasks. In the second part, soft sensors based on engineering and biological characterizations of these vessels are introduced and explained, enabling researchers to predict process values and estimate growth curves. The last part consists of the application of mechanistic and kinetic models for an improved process understanding and an enhanced culture growth prediction.

13:35 - 14:05 30 mins
Info
Downstream Processing
The challenges of purifying Highly Potent Neurotoxins
  • Michael Cornish - DSP Technical Specialist 2, Ipsen Biopharm Limited

Botulinum neurotoxin is effective in the treatment of several movement disorders. Native BoNT/A is comprised of a family of highly related neurotoxins produced by Clostridium botulinum bacteria and BoNT/A (subtype A1) is notable as the strain used to produce the commercial products such as abobotulinumtoxinA (Dysport).
An increased understanding of the structure-function relationship of BoNT provides an opportunity to engineer recombinant (r) BoNTs with unique pharmacologic properties and therapeutic applications. This presentation will describe the challenges associated with Process Development and manufacture for rBoNT products.

13:35 - 14:05 30 mins
Continuous Processing
PAT Assisted Control Strategy for Continuous Downstream Processing
  • Margit Holzer - Scientific Director, Ulysse Consult
13:35 - 14:05 30 mins
Bioprocess Analytics and Control Strategies
PAT Assisted Control Strategy for Continuous Downstream Processing
  • Margit Holzer - Scientific Director, Ulysse Consult
13:35 - 14:05 30 mins
Vaccines
Please move to another track
13:35 - 14:05 30 mins
Industry 4.0
Please move to another track
13:35 - 14:05 30 mins
Info
Viral Safety
Rapid Methods for Adventitious Virus Detection and Sterility Assurance: How can we achieve broad adoption?
  • Cristina Barbirato - Senior Scientist - Scientific and Regulatory Expertise of BQC Biopharma,, Merck

As part of the BioPhorum Technology Roadmapping Phorum, Project “RAVnS” is focused on Rapid methods for Adventitious Virus Detection and Sterility Assurance.

This project contributes to the goals of the BioPhorum 1st edition BioManufacturing Technology Roadmap to reduce production lead time by reducing product lot release times from weeks with current methods to days with innovative methods.

Team members consist of industry professionals from over 10 biopharmaceutical companies who are all interested in driving the adoption of potential solutions.


To collate information on current testing regimes and interest/activities in rapid innovative methods surveys were conducted. Questions included identifying the main point of dissatisfaction with current methods are, barriers to adoption, and what activities would be useful in driving adoption of regulatory compliant release testing. Because the expectation is that methods will continue to evolve, the survey purposely did not focus on technology platforms, but rather focused on generic points to consider for implementing new methods which will serve as the basis for today’s and future methods.


Participants of the survey were identified and selected by the group to be subject matter experts in this topic. Comments and results from the survey are presented herein.

13:35 - 14:05 30 mins
Info
Cell Line Development & Engineering
Designing an Artificial Golgi Reactor as an Alternative to Cell Line Engineering
  • Elli Makrydaki - Graduate Student, Dept of Chemical Engineering, Imperial College London

The dominating method in producing therapeutically relevant proteins such as mAbs with the desired glycosylation profile is the traditional cell-line engineering of host cells such as mammalian cells. However, the lack of strict control can lead to increased product heterogeneity. We propose an artificial Golgi reactor for in vitro glycosylation where by immobilizing selected glycosyltransferases we aim to achieve targeted glycosylation with enhanced product quality.

14:05 - 14:35 30 mins
Info
Cell Culture and Upstream Process Development
Achieving desired protein quality profiles through optimization of media and supplements
  • Stacy Holdread - R&D Staff Scientist, BD Biosciences Advanced Bioprocessing

Attaining desirable and consistent protein quality attributes is critical to achieving a biologically functional monoclonal antibody (mAb), so controlling factors that affect these key attributes is critical for a successful bioproduction run.  In addition to increasing mAb yield, media and supplements can be used to consistently achieve the desired protein quality profile.   This presentation will demonstrate how the optimization of media and supplements provides a mechanism to create a high-performance process that consistently yields the required protein quality attributes.

14:05 - 14:35 30 mins
Info
Downstream Processing
Miniaturization and Parallelization for Downstream Purification of Microbial Expressed Proteins
  • Cécile Brocard - Director Downstream Development, Biopharma Process Science, Boehringer Ingelheim RCV GmbH & Co KG

We present our holistic approach based on a HTPD platform to lever the complexity of manufacturing development for non-platform biotherapeutics. Integration of the whole process chain including fermentation, purification and analytics allows for examination of interdependencies between upstream and downstream development. Our automated screening and optimization unit operations can either be applied as standalone module or in combination as miniaturized process chains. Here we present case studies showing a) the applicability of our HTPD platform during optimization of the fermentation process and b) the potential of our HTPD platform for troubleshooting activities focused on the depletion of a product-related

impurity from the drug substance. This strategy facilitated the assessments of the influence of changes in the upstream conditions on the whole purification process.

14:05 - 14:35 30 mins
Continuous Processing
Chromatographic Clarification as a Tool to Enhance Continuous Processing
  • Sophie Muczenski - Specialist Application Engineer, 3M
14:05 - 14:35 30 mins
Bioprocess Analytics and Control Strategies
Please move to another track
14:05 - 14:35 30 mins
Info
Vaccines
A Challenge with Single-Use Technology: Protecting Bulk Drug Substance (DS) during cold chain handling, storage, and transport Joe Cintavey, Product Specialist, Gore & Associates
  • Joe Clintavey - Product Specialist, Gore & Associates

The issue of single-use container durability during cold chain handling is well known in the biopharmaceutical market, particularly at freeze and transport temperatures down to -80C. The extractables and leachables profile of materials commonly used in containers is another concern. This presentation will discuss novel technologies that address both the durability and purity challenges that biopharmaceutical manufacturers face.

14:05 - 14:35 30 mins
Info
Industry 4.0
Self-Learning Design of Experiments for Bioprocess Platforms
  • Barbara Pretzner - PhD Candidate, TU Wien

The development of new bioprocesses, yielding into pharmaceuticals such as monoclonal antibodies, is highly cost-intensive and time consuming. To reduce the complexity of such a process development, the establishment of platform processes has proven as a fast-track method. Although platform technologies have proved to accelerate the development of biopharmaceuticals, the design of a novel bioprocess based on a platform is anything but trivial. Many experiments have to be performed to guarantee robust manufacturing. The Design of Experiments, or DoE, is a core element when it comes to tackling research and experiments in a clearly structured manner. However, current statistical DoE approaches cannot leverage prior knowledge from previous processes, which forms an untapped potential. Here we present a novel, self-learning DoE workflow based on Bayesian statistics with particular applicability to bioprocess platforms. Especially in biopharmaceutical DoEs are adopted early on in process development, validation up to trouble shooting in routine manufacturing. Therefore, goal is to extract as much information as possible with minimal amount of experimental effort and carry over knowledge from one development stage to another. This will be demonstrated on a case study.

14:05 - 14:35 30 mins
Viral Safety
Next-Generation Sequencing vs Traditional Methods: Considerations and Proof of Concept Data for the Development of a Next-Generation Sequencing Method for Adventitious Virus Detection
  • Maria Bednar - Scientist I, AT Virology, Biogen, USA
14:05 - 14:35 30 mins
Info
Cell Line Development & Engineering
Structural and epitranscriptomic manipulation of RNA to enhance transgene expression
  • Dr. Niall Barron, PhD - Director, National Institute for Cellular Biotechnology

The translation of circular mRNA represents an interesting possibility for improving recombinant protein production. Initiation and termination are two rate limiting steps of translation therefore by encoding a gene lacking a stop codon on a circular RNA molecule we generated an infinite EPO open reading frame and demonstrate the production of secreted protein from a circular mRNA in mammalian cells. In addition the use of an epitranscriptomic approach to improving gene expression will be presented.

14:35 - 15:05 30 mins
Info
Cell Culture and Upstream Process Development
Automation and Digitalization in Upstream Process Development: Embedding advanced microscale bioreactors (ambr) in an efficient sample and data workflow
  • Timo Frensing - Senior Scientist, Large Molecule Research, Roche Diagnostics GmbH

High-throughput USP development can be supported by a combination of microscale bioreactors such as ambr® (Sartorius), efficient sample processing and analytics via a Fluent® pipetting robot (Tecan) and the Cedex Bio HT Analyzer (Roche Diagnostics), and last but not least an automated data processing that connects and integrates all devices.

14:35 - 15:05 30 mins
Downstream Processing
High Throughput Process Development Tools for Optimizing a Commercial Manufacturing Process
  • Dominik Mittergradnegger - Head Downstream Process Development, Shire
14:35 - 15:05 30 mins
Continuous Processing
How to Incorporate Advanced Analytics in Downstream Processing – To Shorten Timelines and Enable Continuous Processing
  • Fabian Steinebach, Ph.D - Manufacturing Scientist, Biogen
14:35 - 15:05 30 mins
Bioprocess Analytics and Control Strategies
How to Incorporate Advanced Analytics in Downstream Processing – To Shorten Timelines and Enable Continuous Processing
  • Fabian Steinebach, Ph.D - Manufacturing Scientist, Biogen
14:35 - 15:05 30 mins
Vaccines
Implementation of membrane chromatography for adenovirus downstream process intensification
  • Helge Abrecht - Expert Scientist, Cell & Viral Drug Substance, GSK Vaccines, Belgium
14:35 - 15:05 30 mins
Info
Industry 4.0
Automation and Digitalization in Upstream Process Development: Embedding advanced microscale bioreactors (ambr) in an efficient sample and data workflow
  • Timo Frensing - Senior Scientist, Large Molecule Research, Roche Diagnostics GmbH

High-throughput USP development can be supported by a combination of microscale bioreactors such as ambr® (Sartorius), efficient sample processing and analytics via a Fluent® pipetting robot (Tecan) and the Cedex Bio HT Analyzer (Roche Diagnostics), and last but not least an automated data processing that connects and integrates all devices.

14:35 - 15:05 30 mins
Viral Safety
Viral Segregation Strategy for Flexible Manufacturing Facility Designs
  • Bonnie Shum - Senior Engineer, Global Biologics Manufacturing Sciences and Technology (MSAT), Genentech, a member of the Roche Group
14:35 - 15:05 30 mins
Info
Cell Line Development & Engineering
Putting The Horse Before The Cart: Designing Gene Expression Constructs For CHO Cell Engineering
  • Adam Brown, Ph.D. - Lecturer, University of Sheffield

Manufacture of non-natural, engineered protein formats will require purpose-built designer cell factories. While a great deal of effort has been devoted to identifying target genes for CHO cell engineering, relatively little has been spent figuring out to optimally express them. This presentation discusses design rules for creating plasmid vectors encoding complex gene combinations, describing how genetic component compositions can be designed and configured in order to optimize the performance of engineered cell factories.

15:05 - 15:35 30 mins
Info
Cell Culture and Upstream Process Development
Transcriptome Analysis For The Scale-Down Of A CHO Cell Fed-Batch Process
  • Jochem Van Der Veen - Scientist, Upstream Process Development, Synthon Biopharmaceuticals BV

The time and resources required to develop an industrial mAb production process can be reduced by using scale down models. Transcriptomics is a valuable tool to compare cell cultures at various scales, leading to improved understanding of the benefits and limitations of each model system. In turn, this will improve process knowledge and ensure efficient process development.

15:05 - 15:35 30 mins
Info
Downstream Processing
Chromassette®: A stackable chromatography cassette enabling disposable, next-generation bioprocessing
  • Guido Ströhlein, PhD, MBA - Global Director Technology and Development, JSR Micro NV

Chromassette®, a novel technology platform in DSP, is a stackable, disposable and pre-packed chromatography cassette with an integrated resin bed support. Chromassette combines the separation capabilities of chromatography resins with the convenience of a pre-packed, modular cassette as shown in a range of application examples, including hyper-productive PrA capture, continuous chromatography and pilot-scale Chromassette stacking results.

15:05 - 15:35 30 mins
Info
Continuous Processing
Integrated Continuous Bioprocessing Platform Development with Continuous Countercurrent Tangential Chromatograph (CCTC) – New Data, Partnership strategies, Integration, and PAT
  • Oleg Shinkazh - Founder & CEO, Chromatan Corporation

• Steady-state CCTC data from multiple modalities
• PAT and manufacturing – overcoming challenges with effective partnerships
• Integration of multiple unit operations – challenges and successes and the path forward

15:05 - 15:35 30 mins
Info
Bioprocess Analytics and Control Strategies
Big Data to Smart Data - Digitizing the Biotechnology Industry with BioPhorum
  • Viktor Sandner - Data Scientist, Fujifilm Diosynth Biotechnologies

Big Data, Data Lakes, and AI are the buzzwords of our times, but what does it take for an industry and their suppliers to adopt these technologies willingly? In truth, it requires significant efforts cross-departments to produce and mine a dataset that can be formulated into an interesting machine learning case study. Often, a bigger part of data has to be left unexplored, mostly because it is either not easily accessible, not linked, unlabeled or simply qualitatively not good enough for machine learning. The Biophorum’s Automated Facility – Big Data to Smart Data Workgroup recognized this limitation and has formulated the goal of reducing bioprocess data assembly timelines from 80% to 10% until September 2019 with a proof of concept study (PoC), where the first early results are presented today.

The BioPhorum is a cross-industry consortium that enables the Biopharmaceutical industry to envisage operating scenarios of the future. Subject matter experts in the member companies work together in focused project teams and help to draw the Technology Roadmap that accelerates progress and improves ways of working. These improvements are accessible to its members first, and then to the industry as a whole.

Within this industrial collaboration, we attempt to answer some questions pertinent to a typical data collection process, using a real-world dataset as a case study: at which stations during a bioprocess is data generated and how is data called through different stages of its collection? What unique identifiers or data dictionaries do different groups use? Where and under which format is the data stored? How could data from legacy instruments be enhanced by tagging and context? How does data flow in and out of databases, and which databases are well suited for our industry? How could the lessons learned and the knowledge acquired be cascaded down across groups and departments to ensure continuous improvement?

The excitement around Big Data will certainly not decrease in the next decades. Direct benefits are a reduction in time for investigations by having contextualized data available. More indirect benefits would entail other work streams who can use such labeled data to implement solutions in MVDA, PAT and CPV. For all of this to succeed, key decision-makers of our times need to know what it really means to bring data-related projects to successful fruition. Perhaps the most important component for this change will have to come from the inside: building up confidence and getting the buy-in from individuals to work with data initiatives across organizations will be essential to achieve the required level of digitization.

15:05 - 15:35 30 mins
Info
Vaccines
Consideration for Biosafety testing of viral vectors and vaccines.
  • Richard Adair - Virology and Technical Support Manager, SGS Virology

Regulatory authorities such as the US Food & Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) impose stringent limits on the amount of microbial contaminates and impurities present during the manufacturing of biological medicines, including viral vectors and vaccines. These regulations ensure sterile products and thus patient safety. To establish that the testing procedures are accurate, regulatory authorities require proof of testing before clinical trials can be approved or a batch of commercial biopharmaceuticals or viral vaccines be released. Consequently, all components of the manufacturing process must undergo extensive safety testing to demonstrate identity, stability, and purity.  This talk will examine the considerations for biosafety testing of viral vectors and vaccines.

15:05 - 15:35 30 mins
Info
Industry 4.0
Big Data to Smart Data - Digitizing the Biotechnology Industry with BioPhorum
  • Viktor Sandner - Data Scientist, Fujifilm Diosynth Biotechnologies

Big Data, Data Lakes, and AI are the buzzwords of our times, but what does it take for an industry and their suppliers to adopt these technologies willingly? In truth, it requires significant efforts cross-departments to produce and mine a dataset that can be formulated into an interesting machine learning case study. Often, a bigger part of data has to be left unexplored, mostly because it is either not easily accessible, not linked, unlabeled or simply qualitatively not good enough for machine learning. The Biophorum’s Automated Facility – Big Data to Smart Data Workgroup recognized this limitation and has formulated the goal of reducing bioprocess data assembly timelines from 80% to 10% until September 2019 with a proof of concept study (PoC), where the first early results are presented today.

The BioPhorum is a cross-industry consortium that enables the Biopharmaceutical industry to envisage operating scenarios of the future. Subject matter experts in the member companies work together in focused project teams and help to draw the Technology Roadmap that accelerates progress and improves ways of working. These improvements are accessible to its members first, and then to the industry as a whole.

Within this industrial collaboration, we attempt to answer some questions pertinent to a typical data collection process, using a real-world dataset as a case study: at which stations during a bioprocess is data generated and how is data called through different stages of its collection? What unique identifiers or data dictionaries do different groups use? Where and under which format is the data stored? How could data from legacy instruments be enhanced by tagging and context? How does data flow in and out of databases, and which databases are well suited for our industry? How could the lessons learned and the knowledge acquired be cascaded down across groups and departments to ensure continuous improvement?

The excitement around Big Data will certainly not decrease in the next decades. Direct benefits are a reduction in time for investigations by having contextualized data available. More indirect benefits would entail other work streams who can use such labeled data to implement solutions in MVDA, PAT and CPV. For all of this to succeed, key decision-makers of our times need to know what it really means to bring data-related projects to successful fruition. Perhaps the most important component for this change will have to come from the inside: building up confidence and getting the buy-in from individuals to work with data initiatives across organizations will be essential to achieve the required level of digitization.

15:05 - 15:35 30 mins
Info
Viral Safety
Consideration for Biosafety testing of viral vectors and vaccines.
  • Richard Adair - Virology and Technical Support Manager, SGS Virology

Regulatory authorities such as the US Food & Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) impose stringent limits on the amount of microbial contaminates and impurities present during the manufacturing of biological medicines, including viral vectors and vaccines. These regulations ensure sterile products and thus patient safety. To establish that the testing procedures are accurate, regulatory authorities require proof of testing before clinical trials can be approved or a batch of commercial biopharmaceuticals or viral vaccines be released. Consequently, all components of the manufacturing process must undergo extensive safety testing to demonstrate identity, stability, and purity.  This talk will examine the considerations for biosafety testing of viral vectors and vaccines.

15:05 - 15:35 30 mins
Info
Cell Line Development & Engineering
ambr: systems enabling high throughput biologics development for intensified processes
  • Ian Ransome - Head of Product Management, ambr systems, Sartorius Stedim Biotech

Intensified processing offers many advantages to those developing biotherapeutics.  However, high throughput tools and techniques to expedite the development of cell lines, media and processes have been lacking.

Current approaches are throughput-limited by infrastructure that requires significant operational input, laboratory space and capital investment.  In this update, novel data derived from ambr 15 cell culture perfusion mimics and the ambr 250 high throughput platform will be presented.

15:35 - 16:20 45 mins
Info
Afternoon Coffee and Poster Tour Two

Channel One: 

Poster 4: 15:40

CRISPR/CAS9 MULTIPLEXING OF CHINESE HAMSTER OVARY B4GAL-T1, 2, 3 AND 4 TAILORS N-GLYCAN PROFILES OF MAB AND TOTAL SECRETED HOST CELL PROTEIN

Thomas Amann, Technical University of Denmark

Poster 5: 15:50

THE CHALLENGE OF EMPLOYING HIGH-THROUGHPUT METHODS FOR PROCESS CHARACTERIZATION DURING LATE STAGE DEVELOPMENT OF BIOPHARMACEUTICALS

Susanne Ulrich, Sanofi-Aventis Deutschland GmbH, Germany 

Poster 6: 16:00

A POSTER BY APPLIKON


Channel Two: 

Poster 58: 15:40

CHARACTERIZATION OF CAPTO ADHERE RESIN TO ADDRESS NEW PURIFICATION CHALLENGES FOR MONOCLONAL ANTIBODY PRODUCTION

Julia Sieben, Merck Corsier-sur-Vevey, Switzerland

Poster 59: 15:50

MAGNETIC BEAD PURIFICATION OF ANTIBODIES DIRECTLY FROM NON-CLARIFIED CELL HARVEST AT PILOT-SCALE

Nils Brechmann, PhD, KTH, Sweden

Poster 60: 16:00

ENGINEERING CHARACTERISATION OF SINGLE-USE BIOREACTORS

Ruchika Bandekar, MedImmune

16:20 - 16:50 30 mins
Info
Cell Culture and Upstream Process Development
The Relevance Of Cell Size In A CHO Fed Batch Process: Metabolic And Transcriptomic Characterization
  • Dirk E. Martens - Associate Professor, Bioprocess Engineering, Wageningen University

In a fed-batch process, using a commercially available media system a switch is observed from a cell proliferation phase to a phase where cell division is arrested and cell growth continues in the form of a threefold increase in cell size and dry weight. Metabolic flux and transcriptome analysis is applied to better understand the biological mechanisms associated with this switch.

16:20 - 16:50 30 mins
Continuous Processing
Enabling Industry 4.0 - Data Management and Analysis for Automated and Digitalized Bioprocessing
  • Michael Sokolov - Postdoctoral Fellow and Lecturer, ETH Zurich
16:20 - 16:50 30 mins
Bioprocess Analytics and Control Strategies
Enabling Industry 4.0 - Data Management and Analysis for Automated and Digitalized Bioprocessing
  • Michael Sokolov - Postdoctoral Fellow and Lecturer, ETH Zurich
16:20 - 16:50 30 mins
Industry 4.0
Enabling Industry 4.0 - Data Management and Analysis for Automated and Digitalized Bioprocessing
  • Michael Sokolov - Postdoctoral Fellow and Lecturer, ETH Zurich
16:20 - 16:50 30 mins
Viral Safety
Circulation of HEV in Europe – implications for blood / plasma product safety
  • Maria Farcet - Scientist, Global Pathogen Safety, Takeda
16:20 - 16:50 30 mins
Info
Cell Line Development & Engineering
The Relevance Of Cell Size In A CHO Fed Batch Process: Metabolic And Transcriptomic Characterization
  • Dirk E. Martens - Associate Professor, Bioprocess Engineering, Wageningen University

In a fed-batch process, using a commercially available media system a switch is observed from a cell proliferation phase to a phase where cell division is arrested and cell growth continues in the form of a threefold increase in cell size and dry weight. Metabolic flux and transcriptome analysis is applied to better understand the biological mechanisms associated with this switch.

16:50 - 17:20 30 mins
Info
Cell Culture and Upstream Process Development
Panel Discussion: Integrating New Engineering and Cell Line Development Technologies into Established Workflows
  • Martin J. Allen, Ph.D. - Senior Director, BioProcess Research & Development, Pfizer
  • Christopher Tan - Scientist, Amgen
  • What new technologies have been adopted by industry and used routinely in cell line development?
  • Success rates and realities of engineering tools? e.g. genomics, genome editing, CRISPR, NGS, targeted integration
  • What is the industry status on CRISPR adoption?
  • Are titres and timelines better with new technologies compared to standard approaches?
  • What are the best, efficient and smart ways to use cell line engineering in a workflow?
  • Where and how are industry incorporating new technologies and engineering for clinical and pipeline products when timelines are critical?
16:50 - 16:55 5 mins
Continuous Processing
End of Track
16:50 - 16:55 5 mins
Viral Safety
End of Track
16:50 - 17:20 30 mins
Info
Cell Line Development & Engineering
Panel Discussion: Integrating New Engineering and Cell Line Development Technologies into Established Workflows
  • Martin J. Allen, Ph.D. - Senior Director, BioProcess Research & Development, Pfizer
  • Christopher Tan - Scientist, Amgen
  • What new technologies have been adopted by industry and used routinely in cell line development?
  • Success rates and realities of engineering tools? e.g. genomics, genome editing, CRISPR, NGS, targeted integration
  • What is the industry status on CRISPR adoption?
  • Are titres and timelines better with new technologies compared to standard approaches?
  • What are the best, efficient and smart ways to use cell line engineering in a workflow?
  • Where and how are industry incorporating new technologies and engineering for clinical and pipeline products when timelines are critical?
17:20 - 17:25 5 mins
End of BioProcess International Europe 2019