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Key Sessions

Tony D'Amore, PhD, MBA

Examining the Advances and Challenges in Vaccine Development and Manufacture

Sanofi Pasteur

Brendan Hughes

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

BMS

Showing of Streams
10:00 - 10:45

Morning Coffee & Poster Tour 1

More
Showing of Streams
12:15 - 13:30

Lunch in the Exhibition Hall and Live Labs

More
Showing of Streams
15:30 - 16:15
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
17:15 - 17:20
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
08:20 - 08:30 10 mins
Downstream Processing
Chairpersons Opening Remarks
08:20 - 08:30 10 mins
Continuous Processing
Chairperson's Opening Remarks
08:20 - 08:30 10 mins
Bioprocess Analytics and Control Strategies
Chairperson's Opening Remarks
08:20 - 08:30 10 mins
Vaccines
Chairpersons Opening Remarks
08:20 - 08:30 10 mins
Industry 4.0
Chairpersons Opening Remarks
08:20 - 08:30 10 mins
Viral Safety
Chairpersons Opening Remarks
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
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
09:00 - 09:30 30 mins
Cell Culture and Upstream Process Development
Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Brendan Hughes - Vice President, MS&T, BMS
09:00 - 09:30 30 mins
Downstream Processing
Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Brendan Hughes - Vice President, MS&T, BMS
09:00 - 09:30 30 mins
Continuous Processing
Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Brendan Hughes - Vice President, MS&T, BMS
09:00 - 09:30 30 mins
Bioprocess Analytics and Control Strategies
Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Brendan Hughes - Vice President, MS&T, BMS
09:00 - 09:30 30 mins
Vaccines
Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Brendan Hughes - Vice President, MS&T, BMS
09:00 - 09:30 30 mins
Industry 4.0
Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Brendan Hughes - Vice President, MS&T, BMS
09:00 - 09:30 30 mins
Viral Safety
Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Brendan Hughes - Vice President, MS&T, BMS
09:00 - 09:30 30 mins
Cell Line Development & Engineering
Technology Toolbox for Cell Line Development
  • Holger Laux - Fellow, Novartis Cell Line Development
09:30 - 10:00 30 mins
Cell Culture and Upstream Process Development
Smart Biomanufacturing Facilities of the Future
  • A Representative from IDBS, IDBS
09:30 - 10:00 30 mins
Downstream Processing
Smart Biomanufacturing Facilities of the Future
  • A Representative from IDBS, IDBS
09:30 - 10:00 30 mins
Continuous Processing
Smart Biomanufacturing Facilities of the Future
  • A Representative from IDBS, IDBS
09:30 - 10:00 30 mins
Bioprocess Analytics and Control Strategies
Smart Biomanufacturing Facilities of the Future
  • A Representative from IDBS, IDBS
09:30 - 10:00 30 mins
Vaccines
Smart Biomanufacturing Facilities of the Future
  • A Representative from IDBS, IDBS
09:30 - 10:00 30 mins
Industry 4.0
Smart Biomanufacturing Facilities of the Future
  • A Representative from IDBS, IDBS
09:30 - 10:00 30 mins
Viral Safety
Smart Biomanufacturing Facilities of the Future
  • A Representative from IDBS, IDBS
09:30 - 10:00 30 mins
Cell Line Development & Engineering
Spotlight Presentation
10:00 - 10:45 45 mins
Morning Coffee & Poster Tour 1
10:45 - 11:15 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.

10:45 - 11:15 30 mins
Downstream Processing
Single Use Technologies within Biopharmaceutical Processing
  • Michel Eppink - Director Downstream Processing, Synthon Biopharmaceuticals BV, The Netherlands
10:45 - 11:15 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
10:45 - 11:15 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.

10:45 - 11:15 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.

10:45 - 11:15 30 mins
Industry 4.0
Global Digital Transformation and Implementation of Industry 4.0 in Bioprocessing
10:45 - 11:15 30 mins
Viral Safety
Next generation sequencing efforts at CBER
  • Arifa Khan - Supervisory Microbiologist, FDA
10:45 - 11:15 30 mins
Info
Cell Line Development & Engineering
Structural and epitranscriptomic manipulation of RNA to enhance transgene expression
  • 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.

11:15 - 11:45 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.

11:15 - 11:45 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
11:15 - 11:45 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
11:15 - 11:45 30 mins
Bioprocess Analytics and Control Strategies
Industry 4.0: Status and Application of Predictive Modelling in New Bioprocess Development
  • Alexander Wiedenmann - Associate Director Protein Science and lab head, Boehringer Ingelheim
11:15 - 11:45 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.

11:15 - 11:45 30 mins
Industry 4.0
Industry 4.0: Status and Application of Predictive Modelling in New Bioprocess Development
  • Alexander Wiedenmann - Associate Director Protein Science and lab head, Boehringer Ingelheim
11:15 - 11:45 30 mins
Viral Safety
Testing strategies for adventitious agents: impact of NGS introduction
  • Laurent Mallet - ‎Associate VP, Head of Analytical R&D Europe, Sanofi Pasteur, France
11:15 - 11:45 30 mins
Cell Line Development & Engineering
Application on CRISPR Cas9 to Accelerate Cell Line Development and Engineering
11:45 - 12:15 30 mins
Cell Culture and Upstream Process Development
Spotlight Presentation from AGC
11:45 - 12:15 30 mins
Downstream Processing
Spotlight Presentation form GE Healthcare
11:45 - 12:15 30 mins
Continuous Processing
Spotlight Presentation form PALL
11:45 - 12:15 30 mins
Bioprocess Analytics and Control Strategies
Spotlight Presentation
11:45 - 12:15 30 mins
Vaccines
Spotlight Presentation
  • A Representative from Sartorius, Sartorius
11:45 - 12:15 30 mins
Industry 4.0
Spotlight Presentation
11:45 - 12:15 30 mins
Viral Safety
Spotlight Presentation from Charles River
11:45 - 12:00 15 mins
Cell Line Development & Engineering
Spotlight Presentation
  • A Representative from Polyplus, Polyplus
12:00 - 12:15 15 mins
Cell Line Development & Engineering
Spotlight Presentation
  • A Representative from Selexis, Selexis
12:15 - 13:30 75 mins
Lunch in the Exhibition Hall and Live Labs
13:30 - 14:00 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.

13:30 - 14:00 30 mins
Downstream Processing
Dual Sourcing of Protein A Resin to Mitigate Supply Chain Risk: A Comparative Study to Determine Equivalence
  • Edward Koepf - Senior Scientist, process Biochemistry, Biogen, USA
13:30 - 14:00 30 mins
Continuous Processing
Building a Fully Integrated Continuous Bioprocessing cGMP Plant: Promises It Holds and Lessons Learned from It
  • Samir Varma - General Manager, Head of Manufacturing, Enzene Biosciences
13:30 - 14:00 30 mins
Bioprocess Analytics and Control Strategies
Analytics and real time product release – regulatory perspective
  • Santosh K Nanda - Interdisciplinary Scientist, FDA/CBER, USA
13:30 - 14:00 30 mins
Vaccines
Analytics and real time product release – regulatory perspective
  • Santosh K Nanda - Interdisciplinary Scientist, FDA/CBER, USA
13:30 - 14:00 30 mins
Industry 4.0
Analytics and real time product release – regulatory perspective
  • Santosh K Nanda - Interdisciplinary Scientist, FDA/CBER, USA
13:30 - 14:00 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 MSD

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.

13:30 - 14:00 30 mins
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
14:00 - 14:30 30 mins
Cell Culture and Upstream Process Development
Spotlight Presentation from BD
14:00 - 14:30 30 mins
Downstream Processing
Spotlight Presentation form Bio-Rad
14:00 - 14:30 30 mins
Continuous Processing
PAT Assisted Control Strategy for Continuous Downstream Processing
  • Margit Holzer - Scientific Director, Ulysse Consult
14:00 - 14:30 30 mins
Bioprocess Analytics and Control Strategies
PAT and Process Control Strategies
  • Margit Holzer - Scientific Director, Ulysse Consult
14:00 - 14:30 30 mins
Vaccines
Spotlight Presentation from Bio-Rad
14:00 - 14:30 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.

14:00 - 14:30 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
14:00 - 14:30 30 mins
Cell Line Development & Engineering
Characterizing Clone Performance: A Union of Structure and Sequencing
  • Steven Huhn - Senior Scientist, Merck
14:30 - 15:00 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.

14:30 - 15:00 30 mins
Downstream Processing
High Throughput Process Development Tools for Optimizing a Commercial Manufacturing Process
  • Dominik Mittergradnegger - Head Downstream Process Development, Shire
14:30 - 15:00 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
14:30 - 15:00 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
14:30 - 15:00 30 mins
Vaccines
Discussion Panel: Analytics in Vaccine Development
14:30 - 15:00 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.

14:30 - 15:00 30 mins
Viral Safety
Viral Segregation Strategy for New Facility Designs
  • Bonnie Shum - Engineer II, Global Biologics Manufacturing Sciences and Technology (MSAT), Genentech, a member of the Roche Group
14:30 - 15:00 30 mins
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
15:00 - 15:30 30 mins
Cell Culture and Upstream Process Development
Spotlight Presentation
  • A Representative from Applikon, Applikon
15:00 - 15:30 30 mins
Downstream Processing
Spotlight Presentation
  • A Representative from JSR, JSR
15:00 - 15:30 30 mins
Continuous Processing
Spotlight Presentation
  • A Representative from Chromatan, Chromatan
15:00 - 15:30 30 mins
Bioprocess Analytics and Control Strategies
Big Data to Smart Data
  • A Representative from BPOG, BPOG Technology Roadmap Group
15:00 - 15:15 15 mins
Vaccines
Spotlight Presentation
  • A Representative from Expres2ion Bio, Expres2ion Bio
15:00 - 15:30 30 mins
Industry 4.0
Big Data to Smart Data
  • A Representative from BPOG, BPOG Technology Roadmap Group
15:00 - 15:30 30 mins
Viral Safety
Spotlight Presentation
  • A Representative from SGS, SGS Virology
15:00 - 15:30 30 mins
Cell Line Development & Engineering
Spotlight Presentation
  • A Representative from Sartorius, Sartorius
15:15 - 15:30 15 mins
Vaccines
Spotlight Presentation
15:30 - 16:15 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

16:15 - 16:45 30 mins
Cell Culture and Upstream Process Development
Automation, Scale Down Models and High Throughput Process Development
  • Niklas Zink - Scientist, Upstream Development, CSL Behring
16:15 - 16:45 30 mins
Downstream Processing
Development of a Novel Affinity Resin for Capture of Recombinant Botulinum Toxin
  • Michael Cornish - DSP Technical Specialist 2, Ipsen Biopharm Limited
16:15 - 16:45 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
16:15 - 16:45 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
16:15 - 16:45 30 mins
Vaccines
A presentation from GSK Vaccines - pending final confirmation
  • Helge Abrecht - Expert Scientist, Cell & Viral Drug Substance, GSK Vaccines, Belgium
16:15 - 16:45 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
16:15 - 16:45 30 mins
Viral Safety
Circulation of HEV in Europe – implications for blood / plasma product safety
  • Maria Farcet - Scientist, Global Pathogen Safety, Shire
16:15 - 16:45 30 mins
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
16:45 - 17:15 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.

16:45 - 17:15 30 mins
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
16:45 - 17:15 30 mins
Continuous Processing
Viral Clearance Testing in a Continuous Manufacturing Process
  • Konstantin Zoeller - Fellow, Scientific leader, Gene Therapy, Novartis
16:45 - 17:15 30 mins
Bioprocess Analytics and Control Strategies
Future and Use of Digitalisation in Bioprocessing
16:45 - 17:15 30 mins
Industry 4.0
Panel Discussion: Future and Use of Digitalisation in Bioprocessing
16:45 - 17:15 30 mins
Viral Safety
Viral Clearance Testing in a Continuous Manufacturing Process
  • Konstantin Zoeller - Fellow, Scientific leader, Gene Therapy, Novartis
16:45 - 17:15 30 mins
Cell Line Development & Engineering
Panel Discussion: Integrating New Engineering and Cell Line Development Technologies into Established Workflows
17:15 - 17:20 5 mins
End of BioProcess International Europe 2019