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Key Sessions

Rahul Singhvi

Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing

Takeda Vaccines, Inc

David James

KEYNOTE PRESENTATION: New Parts and Systems for CHO Cell Synthetic Biology

University of Sheffield

07:30 - 08:20

Registration and Morning Coffee

Showing of Streams
10:30 - 11:15

Morning Coffee and Networking

Showing of Streams
12:50 - 14:05

Lunch in the Exhibition Hall and Live Labs

Showing of Streams
15:35 - 16:05

Afternoon Coffee Break

Showing of Streams
17:05 - 17:15

Plenary Changeover

17:15 - 17:45

Closing Plenary - Next Generation Bioprocessing - A Representative from Sartorius

17:45 - 19:45

End of Conference Day Two and Evening Entertainment

07:30 - 08:20 50 mins
Registration and Morning Coffee
08:20 - 08:30 10 mins
Cell Culture and Upstream Process Development
Chairperson's Opening Remarks
08:20 - 08:30 10 mins
Downstream Processing
Chairperson's Opening Remarks
08:20 - 08:30 10 mins
Process Development and Characterisation Strategies
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
Chairperson's Opening Remarks
08:30 - 09:00 30 mins
Cell Culture and Upstream Process Development
Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing
  • Rahul Singhvi - Chief Operating Officer, Takeda Vaccines, Inc
more
08:30 - 09:00 30 mins
Downstream Processing
Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing
  • Rahul Singhvi - Chief Operating Officer, Takeda Vaccines, Inc
more
08:30 - 09:00 30 mins
Process Development and Characterisation Strategies
Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing
  • Rahul Singhvi - Chief Operating Officer, Takeda Vaccines, Inc
more
08:30 - 09:00 30 mins
Bioprocess Analytics and Control Strategies
Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing
  • Rahul Singhvi - Chief Operating Officer, Takeda Vaccines, Inc
more
08:30 - 09:00 30 mins
Vaccines
Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing
  • Rahul Singhvi - Chief Operating Officer, Takeda Vaccines, Inc
more
08:50 - 09:00 10 mins
Viral Safety
Chairperson's Opening Remarks
  • Thomas R. Kreil - Senior Director, Global Pathogen Safety, Shire, Austria
more
08:50 - 09:00 10 mins
Cell Line Development & Engineering
Chairperson's Opening Remarks
09:00 - 09:30 30 mins
Cell Culture and Upstream Process Development
Future Strategies for Bioprocessing - A Representative from Pall Life Sciences
09:00 - 09:30 30 mins
Downstream Processing
Future Strategies for Bioprocessing - A Representative from Pall Life Sciences
09:00 - 09:30 30 mins
Process Development and Characterisation Strategies
Future Strategies for Bioprocessing - A Representative from Pall Life Sciences
09:00 - 09:30 30 mins
Bioprocess Analytics and Control Strategies
Future Strategies for Bioprocessing - A Representative from Pall Life Sciences
09:00 - 09:30 30 mins
Vaccines
Future Strategies for Bioprocessing - A Representative from Pall Life Sciences
09:00 - 09:30 30 mins
Viral Safety
Important Aspects for Virus Safety of Advanced Therapy Medicinal Products (ATMPs) – a regulatory perspective
  • Albert Stühler - Deputy Head, Virus Safety, Paul-Ehrlich-Institut
more
09:00 - 09:30 30 mins
Cell Line Development & Engineering
KEYNOTE PRESENTATION: New Parts and Systems for CHO Cell Synthetic Biology
  • David James - Professor of Bioprocess Engineering, University of Sheffield
more

Synthetic biology based on the “Design-Build-Test-Learn” cycle offers a new paradigm for CHO cell engineering, where it is possible to engineer the host cell factory in a product specific manner via combinatorial “tuning” of discrete cellular synthetic processes.  This approach permits “one-size-fits-all” genetic vectorology and mechanistically blind screening of transfected cells to be replaced with tailored design and construction of specifically fit-for-purpose cell factories.  This engineering design system relies upon a toolbox of synthetic parts with user-defined functionality that work in synchrony to enable product manufacturability.

09:30 - 10:00 30 mins
Cell Culture and Upstream Process Development
Future Process Development Strategies to Improve Process Productivity and Increase Capacity
  • Judy Chou - SVP and Head of Biotech, Bayer Pharmaceuticals
more
09:30 - 10:00 30 mins
Downstream Processing
Future Process Development Strategies to Improve Process Productivity and Increase Capacity
  • Judy Chou - SVP and Head of Biotech, Bayer Pharmaceuticals
more
09:30 - 10:00 30 mins
Process Development and Characterisation Strategies
Future Process Development Strategies to Improve Process Productivity and Increase Capacity
  • Judy Chou - SVP and Head of Biotech, Bayer Pharmaceuticals
more
09:30 - 10:00 30 mins
Bioprocess Analytics and Control Strategies
Future Process Development Strategies to Improve Process Productivity and Increase Capacity
  • Judy Chou - SVP and Head of Biotech, Bayer Pharmaceuticals
more
09:30 - 10:00 30 mins
Vaccines
Future Process Development Strategies to Improve Process Productivity and Increase Capacity
  • Judy Chou - SVP and Head of Biotech, Bayer Pharmaceuticals
more
09:30 - 10:00 30 mins
Viral Safety
NGS – Progress and Updates
  • Laurent Mallet - ‎Associate VP, Head of Analytical R&D Europe, Sanofi Pasteur, France
more
  • Sensitivity
  • Use of NGS in the characterisation of cell substrates
  • Interest group updates
09:30 - 10:00 30 mins
Cell Line Development & Engineering
Systems and Synthetic Biology: Next Generation Tools for Cell Line Development
  • Lin Zhang - Research Fellow, Pfizer
more
10:00 - 10:30 30 mins
Cell Culture and Upstream Process Development
Next Generation Process Development – Platforms, Plants and Products
10:00 - 10:30 30 mins
Downstream Processing
Next Generation Process Development – Platforms, Plants and Products
10:00 - 10:30 30 mins
Process Development and Characterisation Strategies
Next Generation Process Development – Platforms, Plants and Products
10:00 - 10:30 30 mins
Bioprocess Analytics and Control Strategies
Next Generation Process Development – Platforms, Plants and Products
10:00 - 10:30 30 mins
Vaccines
Next Generation Process Development – Platforms, Plants and Products
10:00 - 10:30 30 mins
Viral Safety
Continuous In-Line Virus Inactivation For Next Generation Bioprocessing
  • Sarah Le Merdy - EU Technology Manager Viral Safety, Merck
more

The shift in industry toward connected and continuous monoclonal antibody (mAb) processing has necessitated the development of novel approaches to improve or replace traditional unit operations that rely on hold tanks or operate in bind-elute mode.  One such operation is virus inactivation with low pH, a critical virus reduction step in mAb downstream processing.  Traditional low pH inactivation operations involve one or more large holding tanks in which product is maintained at a target low pH level for a specific period of time, typically 30-60 minutes.  Translating this batch operation to a flow-through continuous process requires careful control of multiple factors to assure effective virus inactivation.

In this presentation, we describe the impact of buffer/mAb composition on the kinetics of virus inactivation.  We address incubation chamber design which has implications for system size, processing times, and safety factor.  Data demonstrating equivalency between batch and in-line systems is also presented.  In-line technology that replaces batch operations and enables effective virus inactivation is expected to play an important role in the development of next generation mAb processing operations.

10:00 - 10:30 30 mins
Cell Line Development & Engineering
Spotlight Presentation: A Representative from Lonza
10:30 - 11:15 45 mins
Morning Coffee and Networking
11:15 - 11:20 5 mins
Cell Culture and Upstream Process Development
Chairperson's Opening Remarks
  • Martina Berger - Associate Director, Cell Culture Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
more
11:15 - 11:45 30 mins
Downstream Processing
Smarter DSP Purification Methods to Meet Upstream Demand
  • Graham McCartney - Technical Services/ Manufacturing Sciences Biotechnology, Eli Lilly
more
11:15 - 11:45 30 mins
Process Development and Characterisation Strategies
From Early Stage to Late Stage Development: How to Characterise a Perfusion-based Vaccine Production Process using QbD?
  • Sarah Touw-Mercier - Scientist USP, Janssen, Pharmaceutical Companies of Johnson and Johnson
more

The biopharmaceutical industry is known for its long time-to-market and for requiring large resources and time investment for product development. The type of activities required at the start of a biopharmaceutical product development focus mainly on designing a suitable process for manufacturing as rapidly as possible material to be tested in pre-clinical and clinical trials. The number of development and GMP batches is at this stage typically limited. This is followed, upon success in early clinical trials, by a process optimization phase, which aims at increasing yields while reducing costs-of-good. Moving on towards late stage development, the manufacturing process needs to be characterized, meaning that its robustness to produce the desired product quality when operated within certain process ranges needs to be demonstrated. This phase is a major component of process development as it translates into generating large numbers of development batches using elaborate analytical methods and advanced statistics, in order to fully study the relations between the manufacturing process and product quality.

Janssen Vaccines has transitioned over the last 3 years from being focused on early stage process development, to being able to accommodate and run full late stage development programs. Janssen Vaccines also embraces the principles of Quality by Design (QbD) in its development programs, where science and risk-based approaches are used as a systematic way to build product and process understanding.

In this presentation, we present the implications of this transition from early to late stage development, with the case-study of the QbD-based characterization of a perfusion-based PER.C6® cell culture process for Adenovirus vaccine production.

11:15 - 11:45 30 mins
Bioprocess Analytics and Control Strategies
Adapting Roche’s Process Monitoring Program to the External Manufacturing Network
  • Kartoa Chow - Senior Engineer, Global Biologics Manufacturing Science and Technology, Genentech, a member of the Roche Group
more

Process monitoring provides early risk identification to ensure reliable supply of quality medicines to patients.  A one-size-fits-all program is not only impractical, but often impossible, for the external manufacturing network.  Rather, the key is to understand the intent of Health Authority requirements to assess state of control, and partner with CMOs to adapt the program based on capabilities and existing systems.

11:15 - 11:45 30 mins
Vaccines
From Early Stage to Late Stage Development: How to Characterise a Perfusion-based Vaccine Production Process using QbD?
  • Sarah Touw-Mercier - Scientist USP, Janssen, Pharmaceutical Companies of Johnson and Johnson
more

The biopharmaceutical industry is known for its long time-to-market and for requiring large resources and time investment for product development. The type of activities required at the start of a biopharmaceutical product development focus mainly on designing a suitable process for manufacturing as rapidly as possible material to be tested in pre-clinical and clinical trials. The number of development and GMP batches is at this stage typically limited. This is followed, upon success in early clinical trials, by a process optimization phase, which aims at increasing yields while reducing costs-of-good. Moving on towards late stage development, the manufacturing process needs to be characterized, meaning that its robustness to produce the desired product quality when operated within certain process ranges needs to be demonstrated. This phase is a major component of process development as it translates into generating large numbers of development batches using elaborate analytical methods and advanced statistics, in order to fully study the relations between the manufacturing process and product quality.

Janssen Vaccines has transitioned over the last 3 years from being focused on early stage process development, to being able to accommodate and run full late stage development programs. Janssen Vaccines also embraces the principles of Quality by Design (QbD) in its development programs, where science and risk-based approaches are used as a systematic way to build product and process understanding.

In this presentation, we present the implications of this transition from early to late stage development, with the case-study of the QbD-based characterization of a perfusion-based PER.C6® cell culture process for Adenovirus vaccine production.

11:15 - 11:45 30 mins
Viral Safety
Update on NGS for Adventitious Virus Detection in Biologics
  • Arifa Khan - Senior Investigator, FDA/CBER
more
11:15 - 11:45 30 mins
Cell Line Development & Engineering
Generation of Superior Host Cell Lines for Biomanufacturing
  • Holger Laux - Fellow, Novartis
more

CHO cells are the most widely used host for large-scale production of recombinant therapeutic proteins. Using transcriptomic approaches we have identified target genes involved in productivity and product quality. Subsequently a variety of novel parental CHO cell lines were generated applying cell line engineering techniques. These novel knockout CHO cell lines are superior in respect to productivity and/or product quality.

11:20 - 11:50 30 mins
Cell Culture and Upstream Process Development
Towards Extracellular Release of Recombinant Proteins during Fermentation Using Antisense Technology
  • Shahin Heshmatifar - Engineering Doctoral Researcher & Teaching Fellow, Department of Biochemical Engineering, UCL, UK
more

Antisense RNA can target and inhibit the synthesis of proteins made by the cell, particularly outer membrane proteins to facilitate secretion of the recombinant product out of the cell during fermentation. This project aims to investigate the impact of inhibition of synthesis of selected outer membrane proteins on the secretion levels, thus having an effective release system. Various products such as alpha-amylase, Fab fragments have been investigated. In case of high secretion yields, the methodology can be adapted by the industry to eliminate cell lysis steps and the overall number of recovery and purification steps in the manufacturing of recombinant proteins can be reduced. The success of this project will be significantly attractive for the industry and it can lead to a new bioprocess strategy within the industry. Yields of 60% has been achieved, an increase from 10%. Yield defined as % of total product in the supernatant. Potential significance for the industry include elimination of cell disruption steps in a bioprocess, significant reduction in levels of contaminants such as HCP, DNA, proteolytic activity is greatly reduced in the culture medium, reduction in number of unit operations in a bioprocess and reduction in process running cost and time

11:45 - 12:15 30 mins
Downstream Processing
Case Study: Root Cause Investigation for a Process Impurity
  • John Henstrand - Principal Scientist I , BioMarin Pharmaceutical Inc. USA
more
11:45 - 12:15 30 mins
Process Development and Characterisation Strategies
Risk Based Approaches to Use of Closed Systems in Renovations of Existing Biopharma API Facilities
  • Lars Hovmand-Lyster - Senior Engineering Specialist, Novo Nordisk, Denmark
more

Companies often experience regulatory challenges during inspection of aging facilities, requiring them initiate projects to optimize product protection and updating to current standards for classified areas for biopharma manufacturing. For a long time the company response have been to improve the existing classified areas or maybe even upgrading to a higher grade of classification. However, it may be more appropriate, and improve product protection, to instead implement the use of closed system processes and downgrade room classification during these facility renovation projects. If closed systems are fully utilised, then a CNC space can be used. As well as reducing complexity of operations, this will reduce capital and operating costs.

This presentation elaborates the work of BPOG members to harmonize the used of closed systems and define risk based tools and approaches to evaluate appropriate room classification across the Biopharmaceutical industry.

11:45 - 12:15 30 mins
Bioprocess Analytics and Control Strategies
Strategies towards the Development of Holistic Bioprocess Monitoring and Control Approaches
  • Julian Morris - Technical Director , Centre for Process Analytics & Control, UK
more
  • Understanding how well your processes are behaving
  • Moving towards Lean Six Sigma Operations – an essential part of QdB for manufacturing capability
  • Development of preventive measures as well as detection methods
  • Integration of diagnostics metrics and systems to track process behaviour and process capability
  • Steps towards the development of a holistic approach for bioprocess monitoring and control
11:45 - 12:15 30 mins
Vaccines
Computational fluid dynamics modeling for fermentation risk reduction during technology transfer and process understanding
  • Tracie Spangler - Associate Principal Scientist, Engineering, Merck & Co., Inc., USA
more

Computational Fluid Dynamics modeling and in-depth scaling calculations have been utilized in partnership to generate data to support equipment design and facility fit during commercialization of a fermentation and primary recovery process for a vaccine candidate across multiple technical transfers. This analysis utilizing representative computer models for tank configurations, supplemented with traditional computational scaling approaches (ungassed P/V, gassed P/V, kLa, etc.), ensures full knowledge of a tank’s mixing and oxygen transfer capabilities allowing process understanding and robust manufacturing across technology transfer to multiple sites. Implementation of this approach across process steps as well as manufacturing sites allows increased knowledge prior to use in a process and/or prior to construction of a new vessel, therefore contributing to successful process transfer with reduced risks upon scale-up/scale-down and new facility introductions.

11:45 - 12:15 30 mins
Viral Safety
Successes and challenges in NGS analysis of crude virus seed material
  • Mark Van Ooij - Principal Scientist, Crucell, The Netherlands
more
11:45 - 12:15 30 mins
Cell Line Development & Engineering
How Novel Technologies can be Applied to Advance CHO-K1 Manufacturing Cell Lines
  • Simon Fischer - Global Bioprocess + Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG
more

Genome editing, next-generation sequencing (NGS) and cell line engineering using microRNAs (miRNAs) have emerged as key technologies towards successful biopharmaceutical process development. We have evaluated and integrated these innovative tools to enhance our state-of-the-art cell line development and characterization processes using our novel BI-HEX® CHO-K1GS manufacturing cell line. This talk will present an overview on our recent achievements in employing these technologies to provide solutions for future bioprocessing challenges.

11:50 - 12:20 30 mins
Cell Culture and Upstream Process Development
Use of Advanced Process Controls for High Titer Biomanufacturing Processes
  • Mark Hammond - Manufacturing Scientist, Manufacturing Sciences, Biogen, Denmark
more
12:15 - 12:45 30 mins
Downstream Processing
Spotlight Presentation - A Representative from Thermo Fisher Scientific
12:15 - 12:45 30 mins
Process Development and Characterisation Strategies
Spotlight Presentation: A Representative from Sartorius
12:15 - 12:45 30 mins
Bioprocess Analytics and Control Strategies
Spotlight Presentation: A Representative from APC
12:15 - 12:45 30 mins
Vaccines
Automated Determination of Viral Particle Yield, Purity, Size and Integrity in Downstream Process Development
  • Matheiu Colomb-Delsuc - Senior Scientist, Electron Microscopy Technologies, Vironova
more

Numerous methods for virus characterization exist but transmission electron microscopy (TEM) is unmatched in providing detailed information on structure, integrity, aggregates and other contaminants. However, due to the need for considerable operator skills, special laboratory facilities and limitations in providing quantitative data it is not routinely used in process development. This case study shows how MiniTEM goes beyond these limitations to provide quantitative data automatically

12:15 - 12:45 30 mins
Viral Safety
Spotlight Presentation: A Representative from Pall LifeSciences
12:15 - 12:30 15 mins
Cell Line Development & Engineering
ChemStress Fingerprinting: A Simple, Novel Platform using Small Molecules to Control and Enhance CHO Cell Factories
  • Jerry Clifford - COO, Valitacell
more

The utility of CHO cell factories derives from exploitation of their acquired genetic/functional variation, which enable industry to identify cell lineages with desirable manufacturing properties. Here we discuss novel technologies engineered to provide a desired level of process control while at the same time enabling optimal leverage of the cell factory using ChemStress Fingerprinting.

12:20 - 12:50 30 mins
Cell Culture and Upstream Process Development
Spotlight Presentation - A Representative from GE Healthcare
12:30 - 12:45 15 mins
Cell Line Development & Engineering
Difficult to Express Proteins: A Novel Plasmid Technology to Increase Product Yields in CHO Cells
  • Marco Cacciuttolo - Head of Operations, Batavia Biosciences
more

Yield is still an area that requires significant improvement for many promising recombinant proteins and antibodies. Novel vector technology enables rapid generation of stable, CHO cell lines able to provide at least 10-fold more product per cell.

12:50 - 14:05 75 mins
Lunch in the Exhibition Hall and Live Labs
14:05 - 14:35 30 mins
Cell Culture and Upstream Process Development
Raman Spectroscopy Monitoring of Product Quality in CHO Cell Culture
  • Brian Horvath - Senior Scientist and Senior Group Leader, Genentech, a member of the Roche Group, USA
more
  • Process-indepedent Raman models are being used to monitor product quality attributes of antibodies and novel format large molecules..
  • Use of Raman leads to radically reduced sample burden in analytical operations.
  • We are working towards a state where Raman is used in GMP to monitor critical quality attributes and affect real-time release of Drug Substance batches.
14:05 - 14:35 30 mins
Downstream Processing
FcRn Affinity Column Chromatography for Therapeutic mAb Characterisation
  • Tilman Schlothauer - Senior Principal Scientist, Roche Innovation Center
more

Fc receptor based affinity chromatography is a new emerging field of Fc functionality analytics. Until now different human FcγReceptors (FcγRIIIa & IIa) and the Fc Receptor neonatal (FcRn) from three species have been utilized for coupling onto Sepharose based matrices. FcRn affinity columns separate antibody species (analytical and preparative) that differ in their affinity to FcRn receptors using conditions that closely resemble the physiological mechanism of interaction between IgG and FcRn. This opens the possibility to easily assess and design FcRn-mediated pharmacokinetic properties of new antibodies, new Ab formats and Fc fusion proteins. Utilizing FcRn affinity columns also allows the analysis of the functional impact of Ab Fc degradation events like oxidation with respect to FcRn receptor binding.

14:05 - 14:35 30 mins
Process Development and Characterisation Strategies
Process Development Strategies for Viral Vectors used in Gene Therapy
  • Franz Gerner - Senior Director Process Development, REGENXBIO Inc., USA
more

In recent years, Gene Therapy has shown promising results, resulting in the need for improved and scalable manufacturing processes due to increased vector and purity demands. Viral vectors present the majority of the gene transfer vehicles used and due to the need of maintaining integrity during the manufacturing process, new approaches for process and analytical technologies must be developed.

14:05 - 14:35 30 mins
Bioprocess Analytics and Control Strategies
Raman Spectroscopy Monitoring of Product Quality in CHO Cell Culture
  • Brian Horvath - Senior Scientist and Senior Group Leader, Genentech, a member of the Roche Group, USA
more
  • Process-indepedent Raman models are being used to monitor product quality attributes of antibodies and novel format large molecules..
  • Use of Raman leads to radically reduced sample burden in analytical operations.
  • We are working towards a state where Raman is used in GMP to monitor critical quality attributes and affect real-time release of Drug Substance batches.
14:05 - 14:35 30 mins
Vaccines
Process Development Strategies for Viral Vectors used in Gene Therapy
  • Franz Gerner - Senior Director Process Development, REGENXBIO Inc., USA
more

In recent years, Gene Therapy has shown promising results, resulting in the need for improved and scalable manufacturing processes due to increased vector and purity demands. Viral vectors present the majority of the gene transfer vehicles used and due to the need of maintaining integrity during the manufacturing process, new approaches for process and analytical technologies must be developed.

14:05 - 14:35 30 mins
Viral Safety
The Use of Detergents in Viral Inactivation – Case Study on a Patented ECO Alternative
  • Edward Koepf - Senior Process Development Scientist, Biogen Idec, USA
more
14:05 - 14:35 30 mins
Cell Line Development & Engineering
Applications of CRISPR-Mediated Genome Engineering Towards Improved CHO Cell Factories
  • Helene Faustrup Kildegaard, Ph.D. - Senior Researcher and Co-Principal Investigator, Novo Nordisk Foundation Center for Biosustainability, University of Denmark, Denmark
more

CHO cells are widely used in the industry as a host for the production of complex pharmaceutical proteins. Thus, accelerated genome engineering of CHO cell factories to improve product yield and quality is of great interest. In this talk, our recent efforts in accelerating genome engineering of CHO cell factories will be presented. Topics will include targeted integration and multiplexing of gene knockouts.

14:35 - 15:05 30 mins
Cell Culture and Upstream Process Development
Real Time Monitoring of CHO Cell Cultures using Dielectric Spectroscopy
  • Christian Kaisermayer - Cell Culture Leader, Manufacturing Sciences & Technology, BioMarin International Ltd., Ireland
more
  • Dielectric spectroscopy provides a robust, non-invasive and online means to achieve continuous monitoring of biomass and other parameters in cell culture
  • The technology fits within the Process Analytical Technology (PAT) framework where the goal of PAT is to improve understanding and control of the manufacturing process
  • The critical frequency Fc was determined for several CHO cultures
  • Different modelling approaches like weighted linear regression, Gaussian kernel smoothing and non-parametric methods were evaluated to correlate permittivity and cell count
  • Dielectric spectroscopy was tested at low and very high cell concentrations to test sensitivity and range of the technology
14:35 - 15:05 30 mins
Downstream Processing
3D Printed Chromatographic Columns
  • Simone Dimartino - Lecturer in Chemical Engineering, Edinburgh University
more

Improved performances. The design and fabrication of 3D printed columns is described, and chromatographic capture of target proteins directly from fermentation broths is demonstrated. Coupling of this 3D printing technology and continuous manufacturing have the potential to revolutionize the downstream industry.

14:35 - 15:05 30 mins
Process Development and Characterisation Strategies
Process Development of Retroviral Vectors for CAR-T Cell Therapies
  • Paulo Fernandes - Senior Scientist, Autolus
more

While retroviral vectors are one of the preferred choices for stable gene expression, the manufacture of these vectors is still limited in titer and quality. This presentation will focus on the process development efforts at Autolus to manufacture retroviral batches in sufficient amounts and with the right quality attributes for T-cell transduction and engineering.

14:35 - 15:05 30 mins
Bioprocess Analytics and Control Strategies
Real Time Monitoring of CHO Cell Cultures using Dielectric Spectroscopy
  • Christian Kaisermayer - Cell Culture Leader, Manufacturing Sciences & Technology, BioMarin International Ltd., Ireland
more
  • Dielectric spectroscopy provides a robust, non-invasive and online means to achieve continuous monitoring of biomass and other parameters in cell culture
  • The technology fits within the Process Analytical Technology (PAT) framework where the goal of PAT is to improve understanding and control of the manufacturing process
  • The critical frequency Fc was determined for several CHO cultures
  • Different modelling approaches like weighted linear regression, Gaussian kernel smoothing and non-parametric methods were evaluated to correlate permittivity and cell count
  • Dielectric spectroscopy was tested at low and very high cell concentrations to test sensitivity and range of the technology
14:35 - 15:05 30 mins
Vaccines
Process Development of Retroviral Vectors for CAR-T Cell Therapies
  • Paulo Fernandes - Senior Scientist, Autolus
more

While retroviral vectors are one of the preferred choices for stable gene expression, the manufacture of these vectors is still limited in titer and quality. This presentation will focus on the process development efforts at Autolus to manufacture retroviral batches in sufficient amounts and with the right quality attributes for T-cell transduction and engineering.

14:35 - 15:05 30 mins
Viral Safety
Triton X-100 – A Strategic Approach for Continued Use in Virus Inactivation
  • Johanna Kindermann - Manager, Shire, Austria
more
  • Triton X-100 is used as particularly effective virus inactivation reagent during the majority of biologics and plasma products manufacturing processes
    • Recently, it has been included on the banned substance list under EU REACH regulations, due to hormone-like effects of degradation products in the environment
    • Continued use for virus inactivation requires REACH authorization
  • Aspects to be considered for REACH authorization
    • Analysis of alternatives
    • Socio-economic analysis
    • Chemical safety report (exposure)
  • How to develop a strategy for authorization of continued TX-100 use as robust virus inactivating agent ?
14:35 - 15:05 30 mins
Cell Line Development & Engineering
Application on CRISPR Cas9 to Accelerate Cell Line Development and Engineering
  • Shamim Rahman - Senior Research Scientist, Novo Nordisk
more
15:05 - 15:35 30 mins
Cell Culture and Upstream Process Development
Impact Of S-Sulfocysteine On Fragments And Trisulfide Bond Linkages In Monoclonal Antibodies
  • Aline Zimmer - Head of R&D. Advanced Cell Culture Technologies, Merck KGaA
more

The quality of recombinant proteins such as monoclonal antibodies produced using Chinese hamster ovary cell based mammalian systems is dependent on many factors, including cell line, process and cell culture media. Due to these factors, the generated product is heterogeneous and may have chemically induced modifications or post-translational modifications that affect antibody stability, functionality and, in some cases, patient safety. This study demonstrates that S-sulfocysteine, a cysteine derivative, can increase the antibody specific productivity in different cell lines cultivated with different processes while minimizing trisulfide linkages in generated mAbs, mainly between heavy and light chain. The supplementation of a cell culture feed with S-sulfocysteine also proved to be useful to reduce the percentage of antibody fragments generated from the monoclonal antibody. Overall, this new component used in the upstream process allows a reduction of product heterogeneity.

15:05 - 15:35 30 mins
Downstream Processing
A New Depletion Technology for Mid-Stream Purification (Case Study)
  • Benoit Mothes - Head of Global DSP Breakthrough Technologies Skill Center, Sanofi
  • Fabien Rousset - Head of Bioseparations Business Unit, Chiral Technologies Europe
more

A new single-use depletion technology for mabs enabling the removal of product and process related impurities, specifically host cell proteins and DNA. Depletion mechanism and data about the use as single product or in a platform frame will be presented.


15:05 - 15:35 30 mins
Process Development and Characterisation Strategies
Spotlight Presentation: A Representative from Asahi Kasei
15:05 - 15:35 30 mins
Bioprocess Analytics and Control Strategies
Octet® Systems Get Ready for Regulated Environments - Providing Data Integrity of Biomolecule Binding Responses in Real-Time and Label-Free
  • Tim Heiseler - Field Applications Specialist, Pall FortéBio
more

Biolayer Interferometry (BLI) technology based Octet® systems have been widely adopted in early research, and development of drug candidates and biotherapeutics. Now, with a comprehensive set of tools for compliance, this label-free technology is gaining traction in process development and quality control (QC) labs for concentration analysis in cell culture and purification, for kinetic and potency analysis of drug-target and drug-Fc receptor interactions, and for stability analysis by assessing changes in activity in stressed and forced degradation samples. Discover the go-to solution providing versatility and flexibility necessary in development combined with rigor and simplicity needed in a QC environment.

15:05 - 15:35 30 mins
Vaccines
Spotlight Presentation
15:05 - 15:35 30 mins
Viral Safety
Continuous processing - The challenges and chances of virus retentive filtration
  • Birte Kleindienst - Junior Product Manager, Virus Clearance, Sartorius Stedim Biotech GmbH
more

The current discussion about continuous processing in upstream and downstream manufacturing for biopharmaceutical products leads to potential new challenges for all unit operations involved such as virus retentive filtration. The main focus of this presentation will be a Design of Experiment (DOE) study performed with a commercially available virus retentive filter to proof the robust virus retention in a fully continuous downstream process. The impact of relevant process parameters such as flow rate/ operating pressure and processing time on the retention performance was determined.

15:05 - 15:35 30 mins
Cell Line Development & Engineering
Spotlight Presentation: A Representative from Maxcyte
15:35 - 16:05 30 mins
Afternoon Coffee Break
16:05 - 16:35 30 mins
Cell Culture and Upstream Process Development
Cell-Size Increase in a CHO-Fed Batch Process: Opportunities for Process Improvements
  • Deborah Hol - PhD Senior Research Scientist Upstream Process Development, Synthon Biopharmaceuticals BV
more
  • Introduction observed cell-size increase in Fed-Batch CHO cultures
  • Metabolic characterization cell-size increase
  • How can PAT tools be used to monitor cell-size increase
  • Opportunities for process improvements
16:05 - 16:35 30 mins
Downstream Processing
How to Manage a Variable Process Parameter in a Validated Process
  • Jan Abildskov - Sr. Manager, Manufacturing Sciences, Biogen
more

This is a small case study where it will be presented how we manage to control a chromatography process parameter that varies dependent on the individual resin lot while maintaining a very high level of process consistency. The process step is critical for product quality and has strict limitations to how other parameters are controlled.

16:05 - 16:35 30 mins
Process Development and Characterisation Strategies
Manufacturing Strategy of a κλ -body for Phase I Clinical Trial
  • Marie Corbier - Analytical Development Laboratory Manager, Novimmune SA
more

Novimmune’s kappa-lambda (κλ) bispecific antibody platform generates fully human bispecific IgG molecules undistinguishable from a standard human immunoglobulin (IgG) molecule. The talk will describe the upstream, downstream and fill and finish processes used for a κλ body manufacturing, as well as the formulation study, pilot/GMP stability data and compatibility results obtained between diluted drug and administration material to be used in clinical trials. The talk will explore the development and optimization of non-conventional analytical tools to support product quality assessment over the different manufacturing steps, to release drug substance and drug product and assess stability of the therapeutic product.

16:05 - 16:35 30 mins
Bioprocess Analytics and Control Strategies
Raman Spectroscopy To Monitor Cell Culture Processes: A Journey Through The Implementation Of A Process Analytical Technology
  • Thomas Rime - USP Postdoctoral Innovation Scientist, Merck
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Raman spectroscopy enables in-situ monitoring of various parameters in cell cultures and thus little disturbance and no contamination risk, which might revolutionize upstream monitoring. The implementation of on-line monitoring based on Raman spectroscopy requires the use of multivariate modeling (e.g. PLS). We present results from on-line monitoring of various bioreactor process parameters and discuss future directions for improvement, and ultimately, the definition of control strategies.

16:05 - 16:35 30 mins
Vaccines
Development of Vaxwave® and TheraT® viral vectors for active immunization against infectious diseases and cancer
  • Anders Lilja - VP Technical Development, Hookipa Biotech, Austria
more
16:05 - 16:35 30 mins
Viral Safety
Cost Effective Prefiltration Strategies for High Throughput Virus Filtration
  • Abhijit Shirke - Scientist, Downstream Operations, CMC Biologics, Teva Pharmaceuticals
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  • Virus filtration is a dedicated step for removal of both endogenous and adventitious virus in most mAb downstream processes. High throughput is essential to keep the cost of virus filters to a reasonable level. This case study will present the throughput comparison of virus filters from four different vendors using multiple mAb feed streams. Development of cost effective prefiltration strategy will be discussed to improve the throughput of virus filters.
16:05 - 16:35 30 mins
Cell Line Development & Engineering
Engineering the CHO Cell
  • Bjørn Voldborg - Director, CHO Cell Line Development, The Novo Nordisk Foundation Center for Biosustainability, Technical University of Denmark
more

At CFB we have established a high throughput genome engineering pipeline using CRISPR-Cas9. The pipeline is being used to generate a panel of engineered CHO cells with improved properties for the production of recombinant therapeutic proteins. We now have a collection of cell lines generating predictable and tailormade glycoprofiles, better product quality and improved growth phenotypes.

16:35 - 17:05 30 mins
Cell Culture and Upstream Process Development
Mastering the digital transformation challenge in biopharmaceutical processing
  • Alessandro Butte, ETH Zurich
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Following the advanced examples of successful process digitalization and automation in the ‘older industries’ such as automotive and finance, several trends could be observed in the biopharmaceutical industry. Over the past decade, one witnessed a shift from yield maximization to quality optimization, the utilization of miniaturized and parallelized high throughput techniques, continuous bioprocessing and continuous data acquisition as well as the utilization of data- and knowledge-driven tools for process analysis, forecasting, monitoring and control. These trends face substantial challenges, as for instance, therapeutic proteins feature several dozen critical quality attributes (CQAs) including their glycosylation and charge variant profiles as well as their aggregated and low molecular weight forms, all which are highly important for the efficacy and safety of the drug.  In order to eventually fulfill the standards and goals of the industry 4.0 era, the methodologies and technologies associated to previous trends must be further developed and extensively utilized in the biopharmaceutical process industry.

Throughout the past years, we elaborated several digital solutions based on advanced engineering statistics, machine learning and deterministic approaches for the analysis, modeling and interpretation of bioprocesses. Furthermore, we integrated them into the process development workflow in several collaboration projects with the biopharmaceutical industry. This presentation will show the possibilities to accelerate development and reduce risks in bioprocessing through digital engineering solutions, and will outline key technology and business drivers to master the digital transformation challenge in bioprocessing.

16:35 - 17:05 30 mins
Downstream Processing
Downstream Development from Microbial Expressed Proteins
  • Cécile Brocard - Director Downstream Development, Biopharma Process Science, Boehringer Ingelheim RCV GmbH & Co KG
more
16:35 - 17:05 30 mins
Process Development and Characterisation Strategies
Feedback from BPOG Environmental Monitoring (EM) Program
  • Patrice Wery - Head of Product Steward – LMSAT Secondary Belgium, GSK
more
16:35 - 17:05 30 mins
Bioprocess Analytics and Control Strategies
Feedback from BMS: Optimisation of Manufacturing Controls and Process Monitoring Programmes
  • Syama Adhibhatta - Senior Manager, Bristol-Myers Squibb, USA
more
16:35 - 17:05 30 mins
Vaccines
Adenovirus vector-based expression of antigens towards vaccine development
  • Santosh K Nanda - Interdisciplinary Scientist, FDA/CBER, USA
more
16:35 - 17:05 30 mins
Viral Safety
Differential Retention of Parvoviruses During Virus Filtration
  • Thomas Nowak - Senior Manager, Viral Validation, CSL Behring, Germany
more

Different animal parvoviruses are in use for spiking studies to determine the reduction capacity of virus filtration processes for small viruses. The use of MVM (Minute Virus of Mice) and PPV (Porcine Parvovirus) is common but also BPV (Bovine Parvovirus) and CPV (Canine Parvovirus) are used. The current assumption is that virus filtration reduction factors obtained with different model viruses are comparable as the size of these parvoviruses is very similar. We have performed studies comparing reduction factors obtained with different parvovirus models designed as separate as well as co-spiking studies. Our studies show that co-spiking is a valid approach to study the influence of the species of parvovirus used on the reduction factor obtained. Our studies show that the virus reduction factor obtained can be significantly influenced by the choice of parvovirus model and is dependent upon the filter type and filtration conditions. The impact of these results on the choice of parvovirus model used for virus validation studies and on the design of the virus filtration process developed is discussed.

16:35 - 17:05 30 mins
Cell Line Development & Engineering
A siRNA Screen Reveals Novel Engineering Targets in CHO Cells that Boost Productivity
  • Gerald Klanert - Post Doc, ACIB – The Austrian Centre of Industrial Biotechnology
more

A whole genome mouse siRNA screening was applied to suspension CHO cells producing and secreting GFP. With this screen, two genes were identified, that, upon knockdown, boost the productivity in CHO cells. The effect of knockdown of these genes varied in different production clones producing either an antibody or an Erythropoietin-Fc fusion protein, indicating cell- and/or subclone specific limitations. However, in each cell line, at least one of the two knockdowns enhanced specific productivity.

17:05 - 17:15 10 mins
Plenary Changeover
17:15 - 17:45 30 mins
Closing Plenary - Next Generation Bioprocessing - A Representative from Sartorius
17:45 - 19:45 120 mins
End of Conference Day Two and Evening Entertainment