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Key Sessions

Stefanos Grammatikos

Bioprocess Innovations in the Era of Acceleration and Intensification

UCB Pharma

Christian Eckermann

Future Strategies for Bioprocessing

Boehringer Ingelheim RCV GmbH & CoKG

07:30 - 08:20

Registration and Morning Coffee

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Showing of Streams
10:30 - 11:25

Morning Coffee and Networking

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Showing of Streams
13:00 - 13:30

Lunch in the Exhibition Hall

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Showing of Streams
15:45 - 16:15

Afternoon Coffee & Networking

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Showing of Streams
17:15 - 17:20
Plenary Changeover

Plenary Changeover

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Showing of Streams
17:50 - 19:20

End of Conference Day Two and Evening Party

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07:30 - 08:20 50 mins
Registration and Morning Coffee
08:20 - 08:30 10 mins
Cell Culture and Upstream Process Development
Plenary Chairperson's Opening Remarks
  • Miriam Monge - Head of Segment Marketing mAbs/ Rec Proteins / Intensified Bioprocessing, Sartorius Stedim FMT S.A.S
08:20 - 08:30 10 mins
Downstream Processing / Continuous Processing
Plenary Chairperson's Opening Remarks
  • Miriam Monge - Head of Segment Marketing mAbs/ Rec Proteins / Intensified Bioprocessing, Sartorius Stedim FMT S.A.S
08:20 - 08:30 10 mins
Process Development and Characterisation Strategies
Plenary Chairperson's Opening Remarks
  • Miriam Monge - Head of Segment Marketing mAbs/ Rec Proteins / Intensified Bioprocessing, Sartorius Stedim FMT S.A.S
08:20 - 08:30 10 mins
Bioprocess Analytics and Control Strategies
Plenary Chairperson's Opening Remarks
  • Miriam Monge - Head of Segment Marketing mAbs/ Rec Proteins / Intensified Bioprocessing, Sartorius Stedim FMT S.A.S
08:20 - 08:30 10 mins
Vaccines
Plenary Chairperson's Opening Remarks
  • Miriam Monge - Head of Segment Marketing mAbs/ Rec Proteins / Intensified Bioprocessing, Sartorius Stedim FMT S.A.S
08:20 - 08:30 10 mins
Viral Safety
Chairpersons Opening Remarks
  • Thomas R. Kreil - Senior Director, Global Pathogen Safety, Takeda
08:30 - 09:00 30 mins
Info
Cell Culture and Upstream Process Development
Bioprocess Innovations in the Era of Acceleration and Intensification
  • Stefanos Grammatikos - VP - Head of Biotech Sciences, UCB Pharma

Current trends in clinical development acceleration and bioprocess intensification impose an unprecedented compression of CMC development timelines and new bioprocessing challenges downstream of the cell culture bioreactor. In this talk I will present a series of innovations we have introduced, some incremental and some potentially disruptive, in an effort to avoid further complications while rising to the latest challenges of bio CMC development and bioprocessing.

08:30 - 09:00 30 mins
Info
Downstream Processing / Continuous Processing
Bioprocess Innovations in the Era of Acceleration and Intensification
  • Stefanos Grammatikos - VP - Head of Biotech Sciences, UCB Pharma

Current trends in clinical development acceleration and bioprocess intensification impose an unprecedented compression of CMC development timelines and new bioprocessing challenges downstream of the cell culture bioreactor. In this talk I will present a series of innovations we have introduced, some incremental and some potentially disruptive, in an effort to avoid further complications while rising to the latest challenges of bio CMC development and bioprocessing.

08:30 - 09:00 30 mins
Info
Process Development and Characterisation Strategies
Bioprocess Innovations in the Era of Acceleration and Intensification
  • Stefanos Grammatikos - VP - Head of Biotech Sciences, UCB Pharma

Current trends in clinical development acceleration and bioprocess intensification impose an unprecedented compression of CMC development timelines and new bioprocessing challenges downstream of the cell culture bioreactor. In this talk I will present a series of innovations we have introduced, some incremental and some potentially disruptive, in an effort to avoid further complications while rising to the latest challenges of bio CMC development and bioprocessing.

08:30 - 09:00 30 mins
Info
Bioprocess Analytics and Control Strategies
Bioprocess Innovations in the Era of Acceleration and Intensification
  • Stefanos Grammatikos - VP - Head of Biotech Sciences, UCB Pharma

Current trends in clinical development acceleration and bioprocess intensification impose an unprecedented compression of CMC development timelines and new bioprocessing challenges downstream of the cell culture bioreactor. In this talk I will present a series of innovations we have introduced, some incremental and some potentially disruptive, in an effort to avoid further complications while rising to the latest challenges of bio CMC development and bioprocessing.

08:30 - 09:00 30 mins
Info
Vaccines
Bioprocess Innovations in the Era of Acceleration and Intensification
  • Stefanos Grammatikos - VP - Head of Biotech Sciences, UCB Pharma

Current trends in clinical development acceleration and bioprocess intensification impose an unprecedented compression of CMC development timelines and new bioprocessing challenges downstream of the cell culture bioreactor. In this talk I will present a series of innovations we have introduced, some incremental and some potentially disruptive, in an effort to avoid further complications while rising to the latest challenges of bio CMC development and bioprocessing.

08:30 - 10:00 90 mins
Info
Viral Safety
Ask the Regulators – Regulatory Breakfast Briefing
  • Albert Stühler - Deputy Head of Virus Safety, Paul-Ehrlich-Institut
  • Arifa Khan - Supervisory Microbiologist, FDA
  • Laurent Mallet - Global Head, Analytical Sciences, Sanofi Pasteur, France

In this hour-long session, delegates will be given the opportunity to pre-submit questions which will then be posed to the regulators and key leaders in the industry. Topics covered historically include:


  • ATMPs
  • Viral safety of raw materials
  • NGS
  • Viral clearance: Removal/Inactivation chromatography, filtration, viral reduction factor and heat
  • In vitro adventitious agent testing
08:50 - 09:00 10 mins
Cell Line Development & Engineering
Chairpersons Opening Remarks
09:00 - 09:30 30 mins
Info
Cell Culture and Upstream Process Development
Operating in a Changing Landscape: Future Process Development Strategies
  • Peter Levison - Executive Director Business Development, Pall Biotech

One significant opportunity for evolutionary change in the biopharmaceutical industry is the widespread adoption of integrated end-to-end processing platforms for biologics manufacturing. Key to the success is the availability of scalable novel upstream and downstream technologies that will not only reduce facility footprint, capital expenses and product cost of goods (CoGs), but also will increase facility flexibility, process productivity, product quality and regulatory acceptance while enhancing patient safety. Until recently production processes tended to follow a single track be it based on stainless steel or single-use typically carried out as a sequence of batch operations. More recently continuous technologies have been introduced to enable end-to-end continuous processing of biologics.

The metaphor that we have adopted for process development going forward is based on a subway map. The ability to get from Point A to Point B can be achieved by multiple routes with journey decisions being made based on specific requirements related to your particular journey. A similar approach can be used for process development where hybrid approaches based on stainless steel, single-use, batch or continuous unit operations can be configured to meet the exacting process requirements. The scalable toolbox offered to the process development and production scientists is gaining in size and so the ability to pick-and-mix technologies to optimise a process whilst improving product quality and patient safety provides a changing landscape in which future process development strategies can evolve.

We will provide insights into these unit operations and how they can be developed into hybrid processes for future processes.


09:00 - 09:30 30 mins
Info
Downstream Processing / Continuous Processing
Operating in a Changing Landscape: Future Process Development Strategies
  • Peter Levison - Executive Director Business Development, Pall Biotech

One significant opportunity for evolutionary change in the biopharmaceutical industry is the widespread adoption of integrated end-to-end processing platforms for biologics manufacturing. Key to the success is the availability of scalable novel upstream and downstream technologies that will not only reduce facility footprint, capital expenses and product cost of goods (CoGs), but also will increase facility flexibility, process productivity, product quality and regulatory acceptance while enhancing patient safety. Until recently production processes tended to follow a single track be it based on stainless steel or single-use typically carried out as a sequence of batch operations. More recently continuous technologies have been introduced to enable end-to-end continuous processing of biologics.

The metaphor that we have adopted for process development going forward is based on a subway map. The ability to get from Point A to Point B can be achieved by multiple routes with journey decisions being made based on specific requirements related to your particular journey. A similar approach can be used for process development where hybrid approaches based on stainless steel, single-use, batch or continuous unit operations can be configured to meet the exacting process requirements. The scalable toolbox offered to the process development and production scientists is gaining in size and so the ability to pick-and-mix technologies to optimise a process whilst improving product quality and patient safety provides a changing landscape in which future process development strategies can evolve.

We will provide insights into these unit operations and how they can be developed into hybrid processes for future processes.


09:00 - 09:30 30 mins
Info
Process Development and Characterisation Strategies
Operating in a Changing Landscape: Future Process Development Strategies
  • Peter Levison - Executive Director Business Development, Pall Biotech

One significant opportunity for evolutionary change in the biopharmaceutical industry is the widespread adoption of integrated end-to-end processing platforms for biologics manufacturing. Key to the success is the availability of scalable novel upstream and downstream technologies that will not only reduce facility footprint, capital expenses and product cost of goods (CoGs), but also will increase facility flexibility, process productivity, product quality and regulatory acceptance while enhancing patient safety. Until recently production processes tended to follow a single track be it based on stainless steel or single-use typically carried out as a sequence of batch operations. More recently continuous technologies have been introduced to enable end-to-end continuous processing of biologics.

The metaphor that we have adopted for process development going forward is based on a subway map. The ability to get from Point A to Point B can be achieved by multiple routes with journey decisions being made based on specific requirements related to your particular journey. A similar approach can be used for process development where hybrid approaches based on stainless steel, single-use, batch or continuous unit operations can be configured to meet the exacting process requirements. The scalable toolbox offered to the process development and production scientists is gaining in size and so the ability to pick-and-mix technologies to optimise a process whilst improving product quality and patient safety provides a changing landscape in which future process development strategies can evolve.

We will provide insights into these unit operations and how they can be developed into hybrid processes for future processes.


09:00 - 09:30 30 mins
Info
Bioprocess Analytics and Control Strategies
Operating in a Changing Landscape: Future Process Development Strategies
  • Peter Levison - Executive Director Business Development, Pall Biotech

One significant opportunity for evolutionary change in the biopharmaceutical industry is the widespread adoption of integrated end-to-end processing platforms for biologics manufacturing. Key to the success is the availability of scalable novel upstream and downstream technologies that will not only reduce facility footprint, capital expenses and product cost of goods (CoGs), but also will increase facility flexibility, process productivity, product quality and regulatory acceptance while enhancing patient safety. Until recently production processes tended to follow a single track be it based on stainless steel or single-use typically carried out as a sequence of batch operations. More recently continuous technologies have been introduced to enable end-to-end continuous processing of biologics.

The metaphor that we have adopted for process development going forward is based on a subway map. The ability to get from Point A to Point B can be achieved by multiple routes with journey decisions being made based on specific requirements related to your particular journey. A similar approach can be used for process development where hybrid approaches based on stainless steel, single-use, batch or continuous unit operations can be configured to meet the exacting process requirements. The scalable toolbox offered to the process development and production scientists is gaining in size and so the ability to pick-and-mix technologies to optimise a process whilst improving product quality and patient safety provides a changing landscape in which future process development strategies can evolve.

We will provide insights into these unit operations and how they can be developed into hybrid processes for future processes.


09:00 - 09:30 30 mins
Info
Vaccines
Operating in a Changing Landscape: Future Process Development Strategies
  • Peter Levison - Executive Director Business Development, Pall Biotech

One significant opportunity for evolutionary change in the biopharmaceutical industry is the widespread adoption of integrated end-to-end processing platforms for biologics manufacturing. Key to the success is the availability of scalable novel upstream and downstream technologies that will not only reduce facility footprint, capital expenses and product cost of goods (CoGs), but also will increase facility flexibility, process productivity, product quality and regulatory acceptance while enhancing patient safety. Until recently production processes tended to follow a single track be it based on stainless steel or single-use typically carried out as a sequence of batch operations. More recently continuous technologies have been introduced to enable end-to-end continuous processing of biologics.

The metaphor that we have adopted for process development going forward is based on a subway map. The ability to get from Point A to Point B can be achieved by multiple routes with journey decisions being made based on specific requirements related to your particular journey. A similar approach can be used for process development where hybrid approaches based on stainless steel, single-use, batch or continuous unit operations can be configured to meet the exacting process requirements. The scalable toolbox offered to the process development and production scientists is gaining in size and so the ability to pick-and-mix technologies to optimise a process whilst improving product quality and patient safety provides a changing landscape in which future process development strategies can evolve.

We will provide insights into these unit operations and how they can be developed into hybrid processes for future processes.


09:00 - 09:30 30 mins
Info
Cell Line Development & Engineering
KEYNOTE: Engineering Complex Traits in CHO Cells through Multiplex Genome Editing
  • Nathan Lewis - Assistant Professor, University of California, San Diego

CHO remains the primary host cell for producing most biotherapeutics. However, there remain many traits that could be improved in the cells. Here, I will discuss recent work in our lab were we utilized systems biology approaches to identify genes to target for host cell engineering to improve cell line and bioprocess quality.

09:30 - 10:00 30 mins
Cell Culture and Upstream Process Development
Future Strategies for Bioprocessing
  • Christian Eckermann - Head of Biopharma Austria & Senior Vice President, Boehringer Ingelheim RCV GmbH & CoKG
09:30 - 10:00 30 mins
Downstream Processing / Continuous Processing
Future Strategies for Bioprocessing
  • Christian Eckermann - Head of Biopharma Austria & Senior Vice President, Boehringer Ingelheim RCV GmbH & CoKG
09:30 - 10:00 30 mins
Process Development and Characterisation Strategies
Future Strategies for Bioprocessing
  • Christian Eckermann - Head of Biopharma Austria & Senior Vice President, Boehringer Ingelheim RCV GmbH & CoKG
09:30 - 10:00 30 mins
Bioprocess Analytics and Control Strategies
Future Strategies for Bioprocessing
  • Christian Eckermann - Head of Biopharma Austria & Senior Vice President, Boehringer Ingelheim RCV GmbH & CoKG
09:30 - 10:00 30 mins
Vaccines
Future Strategies for Bioprocessing
  • Christian Eckermann - Head of Biopharma Austria & Senior Vice President, Boehringer Ingelheim RCV GmbH & CoKG
09:30 - 10:00 30 mins
Cell Line Development & Engineering
Moving Cells with Light: Feasibility Studies for Using the BLI Beacon in CLD Workflows
  • Christine DeMaria - Director, Cell Line Development, Sanofi
10:00 - 10:30 30 mins
Info
Cell Culture and Upstream Process Development
BIOPHARMA TOMORROW: Rethinking efficiency
  • Per Lidén - Digital Product Strategy Manager, GE Healthcare Life Sciences

As an industry, we must get smaller, faster and become more cost-effective in the way we make precision therapies. By automating processes and analyzing data from raw materials, we can re-think every step of drug manufacturing and realize economies at scale. Indeed, digitalization will enable manufacturers of precision health therapeutics to be more successful by adding flexibility, efficiency and confidence. Hear GE Healthcare Life Sciences take on this essential transformation.


10:00 - 10:30 30 mins
Info
Downstream Processing / Continuous Processing
BIOPHARMA TOMORROW: Rethinking efficiency
  • Per Lidén - Digital Product Strategy Manager, GE Healthcare Life Sciences

As an industry, we must get smaller, faster and become more cost-effective in the way we make precision therapies. By automating processes and analyzing data from raw materials, we can re-think every step of drug manufacturing and realize economies at scale. Indeed, digitalization will enable manufacturers of precision health therapeutics to be more successful by adding flexibility, efficiency and confidence. Hear GE Healthcare Life Sciences take on this essential transformation.


10:00 - 10:30 30 mins
Info
Process Development and Characterisation Strategies
BIOPHARMA TOMORROW: Rethinking efficiency
  • Per Lidén - Digital Product Strategy Manager, GE Healthcare Life Sciences

As an industry, we must get smaller, faster and become more cost-effective in the way we make precision therapies. By automating processes and analyzing data from raw materials, we can re-think every step of drug manufacturing and realize economies at scale. Indeed, digitalization will enable manufacturers of precision health therapeutics to be more successful by adding flexibility, efficiency and confidence. Hear GE Healthcare Life Sciences take on this essential transformation.


10:00 - 10:30 30 mins
Info
Bioprocess Analytics and Control Strategies
BIOPHARMA TOMORROW: Rethinking efficiency
  • Per Lidén - Digital Product Strategy Manager, GE Healthcare Life Sciences

As an industry, we must get smaller, faster and become more cost-effective in the way we make precision therapies. By automating processes and analyzing data from raw materials, we can re-think every step of drug manufacturing and realize economies at scale. Indeed, digitalization will enable manufacturers of precision health therapeutics to be more successful by adding flexibility, efficiency and confidence. Hear GE Healthcare Life Sciences take on this essential transformation.


10:00 - 10:30 30 mins
Info
Vaccines
BIOPHARMA TOMORROW: Rethinking efficiency
  • Per Lidén - Digital Product Strategy Manager, GE Healthcare Life Sciences

As an industry, we must get smaller, faster and become more cost-effective in the way we make precision therapies. By automating processes and analyzing data from raw materials, we can re-think every step of drug manufacturing and realize economies at scale. Indeed, digitalization will enable manufacturers of precision health therapeutics to be more successful by adding flexibility, efficiency and confidence. Hear GE Healthcare Life Sciences take on this essential transformation.


10:00 - 10:30 30 mins
Info
Viral Safety
A Holistic Approach to Upstream Viral Safety
  • Trish Greenhalgh - Marketing Manager - Biosafety Products, MilliporeSigma, Merck

All biologics production processes focus on preventing adventitious microorganisms from entering upstream processes. There are numerous technologies to minimize contamination risks but they are not all suitable for every processes. We will discuss the strengths and limitations of these technologies and explain how they can be integrated with advances in testing into a holistic upstream biosafety strategy.

10:00 - 10:30 30 mins
Info
Cell Line Development & Engineering
Accelerating timelines close to the biological limit: A story about the value of implementing novel technologies
  • Thomas Jostock, PhD - Science and Technology Lead / Novartis Leading Scientist, Novartis Pharma AG

State of the art CHO platforms allow generation of high yielding production cell lines with short cycle times. Our technology development strategy combines efforts for further optimizing speed and yield of our CHO platform with continuous expansion of our technology toolbox to deal with challenging molecules and special requirements. By integrating vector and cell line technologies we are aiming for further reducing cycle times and screening efforts of cell line development. Some novel technologies that we have implemented to improve our platform and to expand our technology toolbox will be presented.

10:30 - 11:25 55 mins
Morning Coffee and Networking
11:25 - 11:30 5 mins
Cell Culture and Upstream Process Development
Chairperson's Opening Remarks
11:25 - 11:30 5 mins
Downstream Processing / Continuous Processing
Chairperson's Opening Remarks
  • Andrew Sinclair - President and Founder, BioPharm Services Ltd, United Kingdom
11:25 - 11:30 5 mins
Process Development and Characterisation Strategies
Chairperson's Opening Remarks
11:25 - 11:30 5 mins
Vaccines
Chairperson's Opening Remarks
  • Dan Adams - Co-Founder and Executive Chairman, NextWaveBio
11:25 - 11:30 5 mins
Viral Safety
Chairperson's Opening Remarks
  • Thomas R. Kreil - Senior Director, Global Pathogen Safety, Takeda
11:25 - 11:30 5 mins
Cell Line Development & Engineering
Chairperson's Opening Remarks
11:30 - 12:00 30 mins
Info
Cell Culture and Upstream Process Development
Intensified fed-batch platform to increase productivity
  • Stefania Caso - Technology and Innovation Post-Doctoral Scientist, Merck Serono SA

There is an emerging trend of implementing process intensification in upstream bioprocesses to maximize the cell culture productivity. This presentation provides insight into the development of an intensified fed-batch platform process. It offers a greater process efficiency with a smaller footprint. Examples include production of various monoclonal antibodies and a fusion antibody thanks to the use of this platform. In these cases we increased 2-4 times the titer with a product quality comparable to a classical fed-batch process and in shorter time.

11:30 - 12:00 30 mins
Downstream Processing / Continuous Processing
Streamlining early programs development via toolbox approach
  • Thomas Prouzeau - DSP Scientist, Sanofi
11:30 - 12:00 30 mins
Process Development and Characterisation Strategies
Integrating QbD Principles and Process Characterization Approaches in Developing a Control Strategy for a Non-mAb Biologic
  • Kumar Dhanasekharan - Executive Director, Amicus Therapeutics
11:30 - 12:00 30 mins
Info
Vaccines
Neoantigen-based personalized cancer vaccines: the promise is enormous but so is the cost that at current levels could bankrupt even developed nations’ economies
  • Dan Adams - Co-Founder and Executive Chairman, NextWaveBio

This session will address recent results and efforts to make these vaccines affordable.

11:30 - 12:00 30 mins
Viral Safety
Continuous virus inactivation process using a novel packed-bed reactor
  • Duarte Martins - PhD Student, Lab of Protein Technology and Downstream Processing, Dept of Biotechnology, University of Natural Resources and Life Sciences
  • Johanna Kindermann - Manager, Pathogen Safety, Takeda
11:30 - 12:00 30 mins
Cell Line Development & Engineering
Case Study from Amgen: Accelerating Cell Line Development
  • Christopher Tan - Scientist, Amgen
11:55 - 12:00 5 mins
Bioprocess Analytics and Control Strategies
Chairperson's Opening Remarks
12:00 - 12:30 30 mins
Info
Cell Culture and Upstream Process Development
Pitfalls And Learnings - Transition From Early To Late Stage Process Development Activities
  • Sebastian Schwamb - Laboratory Head, Cell Culture Development in R&D Biologics Development, Sanofi

The presentation will get into current Sanofi state of the art upstream process development centered on late stage programs.

Hereby the theoretical approach, of how to accomplish a successful transition from early to late stage development will be presented.

Furthermore distinct examples of individual development packages (e. g. scale-down) for a IgG-like molecule will be shown.

12:00 - 12:30 30 mins
Downstream Processing / Continuous Processing
Innovative Manufacturing Strategies - What are the Economic Drivers?
  • Andrew Sinclair - President and Founder, BioPharm Services Ltd, United Kingdom
12:00 - 12:30 30 mins
Process Development and Characterisation Strategies
Strategies in Setting Up Phase-Appropriate CQAs for Non-mAb Biologics
12:00 - 12:30 30 mins
Info
Bioprocess Analytics and Control Strategies
Innovative process capability analysis to understanding and managing risk in Biopharma manufacturing network
  • David Cate - Manufacturing Technical Specialist, Global Biologics Manufacturing Sciences and Technology (MSAT), Genentech, a member of the Roche Group

With an increasing expectation by Regulatory agencies to monitor process capability and a highly competitive business environment pressing continuous improvement of the manufacturing processes, Roche has adopted novel indices and graphical visualizations to assess process performance that are statistically robust across the bio and small molecule network. Application of this novel approach enables a data driven decision making strategy to prioritize process and analytical method improvements. The statistical background for the novel approach will be introduced, actual case studies shared and the future potential discussed.

12:00 - 12:30 30 mins
Vaccines
Challenges in Multicomponent Vaccine Development and Manufacturing
  • Dr. A. Krishna Prasad, Ph.D. - Founder, Citranvi, LLC.
12:00 - 12:30 30 mins
Viral Safety
Virus inactivation by laboratory and by manufacturing scale UV-C irradiation in products of Human Plasma
  • Sebastian Lülf - Scientific Manager, Pathogen Saftey, Biotest AG
12:00 - 12:30 30 mins
Info
Cell Line Development & Engineering
The BEST of Both Worlds – Targeted Integration and Multiple Copies: How Can This Go Together For Improved Cell Line Development?
  • Anton Bauer - Senior Scientist, Medical University of Vienna

Targeted Hot Spot integration and multiplication of independent expression units – can this go together and even speed up cell line development? By targeting the Rosa26 Hot Spot in vitro we generated BAC-based expression vectors, which integrated in multiple copies into the CHO host cell chromatin and acted as independent expression units. This allowed us to adapt the selection process and developed long-term stable high-yield production cell lines at an unprecedented speed.

12:30 - 13:00 30 mins
Info
Cell Culture and Upstream Process Development
Innovative Direct Dispense Technology to Control Caking of Hygroscopic Raw Materials and Excipients
  • Willie Hesselink - Technical Application Project Manager, Avantor Inc.

Typical biologic manufacturing consumes hundreds of raw materials including media, supplements, solid process chemicals and excipients.  Weigh and dispensing of these materials consumes as a lot of time, resources and issues such as health of safety due to caking of some of the materials. Caking is a phenomenon that can affect a wide range of hygroscopic solid raw materials and excipients during biopharmaceutical manufacturing (e.g. during buffer preparation, and formulation) and a variety of mechanisms are responsible for the onset of caking transformation. Apart from the direct costs related to caking, there is the risk of lost batches due to unreliable product supply or inconsistence product quality and/or product release. The formation of clumps likely occurs at uncontrolled conditions corresponding to packaging, storage, and transport. Managing of the logistic flow of these hygroscopic materials and releasing them on a timely basis is a delicate task. In order to meet all quality requirements this could result in either increasing inventory levels or implementing non-traditional approach to release the materials in time. In this presentation we will discuss an innovative packaging technology for the storage and dispensing of pre-weighed solid raw materials and excipients that are sensitive for caking, and that is compatible with non-destructive ID-testing tools, such as contact-free Raman spectroscopy. We will discuss various options for savings, and present a case study.

12:30 - 13:00 30 mins
Info
Downstream Processing / Continuous Processing
Case studies on the efficient purification of challenging antibody formats
  • Dr. Laurens Sierkstra - Business Director Purification, Thermo Fisher Scientific

The development of novel antibody therapeutics brings new challenges in the purification of these molecules. Standard chromatography resins, such as Protein A, may not result in the most efficient process. Thermo Scientific™ CaptureSelect™ ligands, focusing on alternative antibody domains, enhance the success of your antibody purification process. From research to full-scale commercial production, the affinity resins provide high target purity in a single step, independent of feedstock. In combination with mild elution to protect the target molecule, these resins provide a platform solution to the industry.

12:30 - 13:00 30 mins
Info
Process Development and Characterisation Strategies
Key Requirements for Virus Filters in Clinical and Commercial Virus Filtration Process Development
  • Konstantin Agolli - Product Manager & BioOptimal TFF Specialist, Asahi Kasei Bioprocess Europe

Establishing a virus filtration step in biopharmaceutical development and manufacturing process may require a large amount of resources. These can be minimized with swift process development, smooth scale-up and worry-free operations. In this presentation, you will learn through different case studies the filtration performances of Planova™ BioEX with regards to robustness, scalability, flexibility and consistency, even in challenging conditions. In addition, how these features contribute in rapid and cost-effective process development during different clinical phases will be explained.


12:30 - 13:00 30 mins
Info
Bioprocess Analytics and Control Strategies
Batch data to multivariate analysis in 30s: eliminating data silos in process development
  • Timothy Gardner, PhD - CEO, Riffyn, Inc.

Today's breakthroughs lie deep in the midst of complex, multivariate data sets. Experimental anomalies and fundamental discoveries often go unnoticed because they are buried in uninterpretable spreadsheets, inaccessible databases, or excessive experimental noise. The cloud-based Riffyn software structures and links experimental designs and measurement data for analysis within seconds after it is collected. Riffyn is helping bioprocessing organizations use this capability to identify unexpected correlations, uncover root causes of error, and deliver right-first-time technology scale-up and technology transfer.


12:30 - 13:00 30 mins
Info
Vaccines
Purity analysis of gene therapy vectors from process development to commercial process
  • Mathieu Colomb-Delsuc, Ph.D. - Senior Scientist, Electron Microscopy Technologies, Vironova

Transmission electron microscopy (TEM) can provide unique insights in the characterization of viral gene delivery platforms

such as AAV or lentivirus. Process development decisions can be speeded up by confirming purity and critical quality attributes. This case study shows how undesired sample characteristics such as:

  • Aggregates
  • Host cell debris and residual DNA
  • Loss of capsid integrity


Easily can be identified and quantified by using automated TEM based image analysis software solutions

12:30 - 13:00 30 mins
Info
Viral Safety
An Integrated Approach to Viral Clearance in Continuous Bioprocessing
  • Nigel Jackson - Principal Engineer R&D, Pall Biotech

Continuous bioprocesses have been proposed as a way of maximising bioprocess efficiency, flexibility and consistency. The potential for higher productivity while at the same time reducing cycle times, buffer usage, resin usage and required footprint are all attractive. However, the innovative approaches required to achieve this can significantly shift the operating design space for the unit operations which deliver process viral clearance. Validation of viral clearance could therefore easily be perceived as more complex, time consuming and expensive.


By applying a consistent approach of prior knowledge assessment, risk assessment and batch simulations of continuous processing, we are able to generate an integrated approach to viral clearance in chromatography, virus inactivation and virus filtration unit operations. We present the approaches and up-to-date results from all these process steps and our current progress on delivering robust and simple methods for continuous viral clearance.

12:30 - 12:45 15 mins
Info
Cell Line Development & Engineering
Automate your Bioprocess CQA Assessment
  • Hannah Byrne - Product Manager, Valitacell

Advances in Cell Line Development Technologies centre on improvements in protein expression technologies and new clone sorting, screening and imaging techniques. Valitacell is offering the biopharmaceutical industry novel methods to transform the complex manufacturing process that produces bio-therapeutic drugs by making it faster than it is today. We aim to fill the gap in the drug manufacturing process, using our fully automatable Quantum fluorescence polarisation technology platform, and our novel ChemStress technology, and, provide answers to key questions as early as possible in order to promote the chance of identifying high producing, stable cell clones in a reduced time-frame.

12:45 - 13:00 15 mins
Cell Line Development & Engineering
Plasmid technology for increased product yields in CHO cells
  • Dr. Sagrario Arias Rivas - Program Manager & Scientific Liaison, Batavia Biosciences
13:00 - 13:30 30 mins
Lunch in the Exhibition Hall
13:30 - 14:15 45 mins
Cell Culture and Upstream Process Development
Live Labs
13:30 - 14:15 45 mins
Downstream Processing / Continuous Processing
Live Labs
13:30 - 14:15 45 mins
Process Development and Characterisation Strategies
Live Labs
13:30 - 14:15 45 mins
Bioprocess Analytics and Control Strategies
Live Labs
13:30 - 14:15 45 mins
Vaccines
Live Labs
13:30 - 13:45 15 mins
Viral Safety
Live Labs
13:30 - 14:15 45 mins
Cell Line Development & Engineering
Live Labs
13:45 - 14:15 30 mins
Info
Viral Safety
Model viruses for viral clearance: Evaluation of the process capacity regarding different types of viruses
  • Philipp Petermann - Head of Viral Clearance Group & Test Facility Manager (GLP), Biologics Testing Solutions, Charles River

Viral clearance studies are performed to demonstrate the potential of the production process to efficiently inactivate and/or remove viruses which potentially contaminate the starting material. In case that the specific initiator viruses cannot be used representative model viruses are the first choice. In this presentation the proof of authority for different model viruses is demonstrated by examples of different process steps.

14:15 - 14:45 30 mins
Info
Cell Culture and Upstream Process Development
From Bench To Production: Addressing The Challenges Of Process Development For Novel Highly Potent Therapeutics
  • Alison Mason - Head of Upstream Development, Ipsen Biopharm

Botulinum neurotoxin (BoNT), produced by Clostridium botulinum, is an effective treatment for several movement disorders. An increased understanding of the structure-function relationship of BoNT molecules provides opportunities to engineer recombinant (r) BoNTs with unique pharmacologic properties and therapeutic applications. This presentation describes the challenges and opportunities associated with process development and GMP manufacture for rBoNT products.

14:15 - 14:45 30 mins
Process Development and Characterisation Strategies
Process Characterization Over Multiple Unit Operations
  • Elisabeth Meulenbroek - Scientist DSP, Janssen Vaccines
14:15 - 14:45 30 mins
Info
Bioprocess Analytics and Control Strategies
Manufacturing Continuous Process Improvement for Enhancing the Product Quality Control Capability by Process Validation Lifecycle and Implementing PAT Platform
  • Ting-Kuo Huang, PhD - Senior Engineer, Genentech, Inc

During biopharmaceutical process development and commercialization, the Process Validation lifecycle is started with Process Design (Stage 1), then followed by Process Performance Qualification (Stage 2) and monitored through Continued Process Verification (Stage 3) for a marketed biologics product. The CPV (Continued Process Verification), per Stage 3 of FDA Process Validation guidance, provides further assurance that a validated process remains in a state of control during the routine GMP manufacturing of a marketed biologics product lifecycle. Raw material lot-to-lot variability may potentially lead to unexpected impact on the cell culture manufacturing process performance and/or product quality attributes (e.g., slower cell growth, low titer performance and/or drifting or shifting of product quality attributes, etc.). Therefore, the manufacturing process performance and product quality attributes (PQA) are continuously monitored, verified and controlled throughout the marketed biologics product lifecycle.

In this presentation, an industry case study will discuss – how a cell culture manufacturing process improvement was identified, evaluated and implemented for stabilizing and controlling the drug substance PQAs to mitigate the potential impact of raw material variability for a marketed biologics product. Multivariate data analysis, scale-down model approaches, and commercial scale process validation were developed, employed and executed to improve the control capability of PQAs. Furthermore, the associated process improvement, CAPA, manufacturing control strategies, and implementing PAT platform in GMP for enhancing product and process monitoring and control during lifecycle will also be presented. The outcome and progress presented in this study are intended to enhance biopharmaceutical manufacturing process knowledge, which is valuable for all partners across the cell culture manufacturing network.

14:15 - 14:45 30 mins
Info
Vaccines
Vaccine Development- Leveraging New Selectivities to Optimize Purification Processes
  • Dr. Carsten Voss - Process Chromatography Application Manager, Bio-Rad Laboratories GmbH
14:15 - 14:45 30 mins
Viral Safety
Environmental restrictions and use of alternatives to Triton X-100 in virus inactivation
  • Johanna Kindermann - Manager, Pathogen Safety, Takeda
  • Jean-Baptiste Farcet - Senior Development Scientist, Process Development, Takeda
14:15 - 14:45 30 mins
Info
Cell Line Development & Engineering
End-to-end Workflow Platform to Speed Up Cell Line Development at Highest Quality Standards
  • Christoph Freiberg - Senior Scientific Consultant, Biologics, Genedata

We have developed an E2E platform that supports the entire bioprocess development workflow by automating cell line development and managing upstream process (USP), downstream process (DSP), analytical and formulation development. The system directly integrates with instruments and enables informed decision-making via its query and reporting infrastructure. We present efficiency and quality gains obtained using the cell line and upstream process development modules of the platform

14:45 - 15:15 30 mins
Info
Cell Culture and Upstream Process Development
Learnings leveraged to de-risk tech transfer
  • Deirdre O’Connell - TS/MS Bioprocess Chemist, Eli Lilly Kinsale Limited

This presentation presents a case study of a tech transfer to Lilly Kinsale. of a commercially approved biologic process. Technology transfer between facilities presents an opportunity to leverage learnings while also looking at validation strategy. Two risks from the transfer are identified and mitigations discussed. Opportunities are examined which simplified operations and enhanced productivity whilst minimizing impact on process performance and reliable supply.

14:45 - 15:15 30 mins
Downstream Processing / Continuous Processing
Achieving Cost and Process Time Savings with Continuous Chromatography and Process Integration for Biotherapeutics
  • Sebastian Vogg - PhD Candidate, ETH Zurich
14:45 - 15:15 30 mins
Process Development and Characterisation Strategies
talk to follow
14:45 - 15:15 30 mins
Info
Bioprocess Analytics and Control Strategies
Modern Analytical Approaches in supporting Process Development
  • Martin Mueller - Director BioProcess Development, MSD

After years of hitting on the product and lifting up even complex biologics to the ‘well-characterized’ category, significant progress has been made with innovative analytical technology focussing on earlier process steps. The benefits and limits of such new control strategies are discussed by case studies applying techniques like PAT, MAM, residual analytics and real-time release approaches.

14:45 - 15:15 30 mins
Vaccines
Improving downstream processing of vaccines and gene therapy vectors with continuous chromatography
  • Manuel Carrondo - Professor of Chemical and Biochemical Engineering, FCT-UNL Vice-President, iBET Portugal
14:45 - 15:15 30 mins
Info
Viral Safety
Effective inactivation of a wide range of viruses by pasteurisation
  • Wolfram Schäfer - Senior Manager, Virus Safety Development, CSL Behring Biotherapies for Life

Pasteurization at 60°C for 10 hours has been implemented in the manufacturing process of therapeutic plasma proteins such as human albumin, coagulation factors, immunoglobulins, and enzyme inhibitors to inactivate blood-borne viruses of concern. A comprehensive compilation of the virus reduction capacity of pasteurization will be presented including the effect of stabilizers used to protect the therapeutic protein from modifications during heat treatment. Virus spiking studies were carried out under the routine manufacturing target variables, such as temperature and product-specific stabilizer composition. Additional studies were also performed under robustness conditions i.e. outside production specifications. Evidence will be provided that pasteurization is a very robust and reliable virus inactivation method with a broad effectiveness against enveloped and non-enveloped viruses encompassing known blood-borne pathogens and emerging or potentially emerging viruses.

14:45 - 15:15 30 mins
Info
Cell Line Development & Engineering
Rapid Development of Cell Lines Suitable for Commercial Manufacturing
  • Martin J. Allen, Ph.D. - Senior Director, BioProcess Research & Development, Pfizer

Cell line development to support early phase clinical programs is often performed on rapid timelines, recognizing that it may be necessary to develop a new cell line to support commercialization if the programs advances to that stage.  This presentation will focus on technologies and strategies that enable the most rapid development of an early phase cell line that is also suitable for commercial manufacturing (single cycle cell line development).        

15:15 - 15:45 30 mins
Info
Cell Culture and Upstream Process Development
Automated Mini-pool approach with integrated analytics for high producing cell line development
  • Cyrielle Corbin, Ph.D. - Team Leader, European Biodevelopment Center, Martillac, Merck

A high producing cell line is required as a starting point for preclinical development of a new drug. Getting this cell line quickly and cost-effectively is key to move forward with cell banking, process development, and IND submission. We will describe an automated mini-pool approach combined to a technological platform that we implemented to address the above requirements. Composed of a Cell imager system associated to an automated incubator and high-throughput analyzer for the productivity performances, this approach allows for the simultaneous screening of several thousand mini-pools. Employing a 3-stage statistical model for further screening allows to reach a high-yield mini-pool, with at least a 2-fold increase of titer compared to a pool-based method. Incorporation of characterization methods throughout the process ensures the final drug product has the highest potency. Integrating statistical analysis with these automated methods creates, screens, and isolates high-producing clones with reduced cost and timelines.

15:15 - 15:45 30 mins
Downstream Processing / Continuous Processing
DAISEP MabXpure: Innovative Purification Strategies for HCP Clearance
  • Dr. Fabien Rousset - Head of DAICEL Bioseparations, Chiral Technologies Europe
15:15 - 15:45 30 mins
Info
Process Development and Characterisation Strategies
A Gmp-Compliant Validation Of Real Time Pcr Assay For Mycoplasma Detection As Routine Quality Control Of Cell Therapy Products
  • Valentina Becherucci, Bsc - Quality Control Laboratory, Cell Factory Meyer, Meyer Children’s Hospital

Manufacturing of cell based products for clinical use involves an ex vivo expansion, which leads to a risk of contamination by microbiological agents. Furthermore, absence of mycoplasma contamination represents a release criteria of a cell-based therapy medical product (CTMP). European Pharmacopoeia (EuPh) offers the possibility to replace official mycoplasma detection methods with Nucleic Acid Amplification (NAT) techniques, after suitable validation. We present a GMP-compliant validation of real time PCR method for mycoplasma detection using MycoSEQTM Mycoplasma Detection Assay (Thermo Fisher Scientific) on Applied Biosystems™ QuantStudio™ 5 Real-Time PCR System (Thermo Fisher Scientific).  As an authorized Italian Cell Factory, we are glad to share our experience , pointing out the practical approach for method validation (i.e interference removal) in order to make it suitable for routine quality control of cell-based therapy medical products.

15:15 - 15:45 30 mins
Info
Bioprocess Analytics and Control Strategies
Using Computational Fluid Dynamics for efficient Scale Up and Tech Transfer of Bioprocesses
  • Becca Dunne - Process Development Engineer - Large Molecule, APC Ltd

CFD uses direct numerical simulations to solve problems involving fluid flows. APC has used CFD to facilitate rapid troubleshooting, scale-up and tech transfer across a variety of equipment sets including mixing vessels, wave-bag reactors, and TFF skids. This presentation will discuss how APC has used CFD to scale up from 3 L laboratory bioreactors to our in-house 250 L pilot plant and characterized a variety of vessels to achieve smooth and efficient tech transfer, eliminating the need for multiple time-consuming and costly experiments.

15:15 - 15:30 15 mins
Vaccines
Development of new S2 cell lines for vaccine production
  • Max Soegaard - Director, Process Development, ExpreS2ion Biotechnologies
15:15 - 15:45 30 mins
Viral Safety
New Solutions for Fully Single-Use Virus Filtration in Manufacturing
  • Anika Manzke - Product Manager Virus Clearance, Sartorius Stedim Biotech, Germany
15:15 - 15:45 30 mins
Info
Cell Line Development & Engineering
Scalable, Helper Virus-Free AAV Production in Suspension
  • Silke Wissing - Vice President R&D, CEVEC

CEVEC has developed a helper virus-free suspension AAV production platform on the basis of the CAP-GT cells. These human suspension cell lines grow to high density in serum free conditions and allow reproducible and high titer production of viral vectors. CEVEC’s stable AAV packaging/producer cell lines enables a consistent quality production of AAV vectors that abolishes the need for transient transfection or helper-virus transduction.

15:45 - 16:15 30 mins
Afternoon Coffee & Networking
16:15 - 16:45 30 mins
Info
Cell Culture and Upstream Process Development
Monitoring The Scale-Up Of A Biopharmaceutical Cell Culture Process Using Raman Spectroscopy At 2000 L Scale In A GMP Environment
  • Rutger Douma - Senior Scientist/Manager Technical Operations, Janssen Biologics

A Raman spectroscopic model was developed using small scale cell culture bioreactor experiments for a new Janssen biopharmaceutical product. This model enabled online substrate, metabolite and product concentration measurements and it was successfully used to monitor the scale-up to a 2000 L fed-batch bioreactor in a GMP environment.

16:15 - 16:45 30 mins
Downstream Processing / Continuous Processing
Intensified Processing - Can I Meet my Viral Safety Targets?
  • Dr. Sladjana Tomić-Škrbić - Manager, Process Development Scientist, Merck
16:15 - 16:45 30 mins
Bioprocess Analytics and Control Strategies
Monitoring The Scale-Up Of A Biopharmaceutical Cell Culture Process Using Raman Spectroscopy At 2000 L Scale In A GMP Environment
  • Rutger Douma - Senior Scientist/Manager Technical Operations, Janssen Biologics
16:15 - 16:45 30 mins
Vaccines
Efforts on the development and licensure of an Ebola vaccine
  • Parimal R. Desai, PhD - Vice President, Global Vaccines & Biologics Commercialization, MSD
16:15 - 16:45 30 mins
Viral Safety
Roche Diagnostics GmbH Case Stud
  • Marc Bieberbach - Senior Research Associate, Roche Diagnostics GmbH
16:15 - 16:45 30 mins
Info
Cell Line Development & Engineering
Making the Most Out of the Data Collected along the CLD Process
  • Anke Mayer-Bartschmid, - Cell and Protein Sciences, Pharmaceuticals Division, , Bayer Pharma

High titers and good product quality are the key features a final production cell line needs to have. Besides many other quality attributes a consistent track record and data integrity are essential to launch the cell line for production. Furthermore, the availability of screening data during cell line development allows for fast analysis and the selection of the best clones. We will present Bayer’s way for tracking and analysis of clone selection data.

16:15 - 16:45 30 mins
Process Development and Characterisation Strategies
How to Use Statistics in a Lifecycle Approach
  • Steven Walfish - Principal Science & Standards Liaison, United States Pharmacopeia (USP)
16:45 - 17:15 30 mins
Cell Culture and Upstream Process Development
Advances in Real-Time Online Monitoring Methods for Product Quality in Cell Culture Bioreactors
  • Keith Wilson - Head of Bioprocess R&D, Novimmune
16:45 - 17:15 30 mins
Downstream Processing / Continuous Processing
Achieving Fully Integrated Downstream Continuous Process - What Challenges Still Remain?
  • Gorazd Hribar - Project Manager, nextBioPharmDSP, Novartis
16:45 - 17:15 30 mins
Bioprocess Analytics and Control Strategies
Advances in Real-Time Online Monitoring Methods for Product Quality in Cell Culture Bioreactors
  • Keith Wilson - Head of Bioprocess R&D, Novimmune
16:45 - 17:15 30 mins
Viral Safety
Feedback from the BPOG Raw Material Variability Workstream
  • Aaron Mack - Engineer III, Biogen
16:45 - 17:15 30 mins
Process Development and Characterisation Strategies
An Improved CHO HCP Detection System for Biopharmaceuticals
  • Mindy Wan, PhD - Director, KBI Biopharma
17:15 - 17:20 5 mins
Plenary Changeover
17:20 - 17:50 30 mins
Info
Cell Culture and Upstream Process Development
Enhanced biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing
  • Jean-Marc Cappia - Head of Segment Marketing Vaccines, Sartorius Stedim Biotech

Key objectives:

The presentation provides an overview of the challenges associated with the increasing adoption of single-use systems (SUS) in vaccines manufacturing and outlines a supply chain and quality strategy where raw material specifications and end to end process controls achieve more consistent biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing.

Bas du formulaire


Abstract

Vaccines manufacturing processes are diverse and complex and require strong commitment to quality for every raw materials and process equipment. With single becoming mainstream technology in commercial manufacture of modern vaccines, there is an increasing reliance on supplier quality and growing regulatory and industry requirement for more transparency on supplier’s quality system and supply chain. Single use suppliers are expected to better characterize their materials and processes, control the variability, understand the impact on vaccine quality and continuously improve their quality systems.

The presentation introduces an integrated supply chain and quality by design strategy whereby SUS integrators partner with polymer and film suppliers to combine material science, film extrusion and bag making expertise. These collaborations help optimize the resins and films and provide better knowledge, specifications and controls of the entire manufacturing process. This in turns allows an in depth characterization and control of extractable substances and particles profiles.

The presentation outlines how establishing resin specifications, film extrusion design spaces and quality agreements can significantly reduce raw material variability, provide consistent biocompatibility and improve product robustness and integrity. End to end process control also enhances assurance of supply and change control.



Audience take-home messages:

  • Resin specification and film design space reduce material variability and improve product quality
  • Control of raw materials and processes enhances single use product biocompatibility & integrity
  • End to end process control also improves assurance of supply and change control for single use products
17:20 - 17:50 30 mins
Info
Downstream Processing / Continuous Processing
Enhanced biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing
  • Jean-Marc Cappia - Head of Segment Marketing Vaccines, Sartorius Stedim Biotech

Key objectives:

The presentation provides an overview of the challenges associated with the increasing adoption of single-use systems (SUS) in vaccines manufacturing and outlines a supply chain and quality strategy where raw material specifications and end to end process controls achieve more consistent biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing.

Bas du formulaire


Abstract

Vaccines manufacturing processes are diverse and complex and require strong commitment to quality for every raw materials and process equipment. With single becoming mainstream technology in commercial manufacture of modern vaccines, there is an increasing reliance on supplier quality and growing regulatory and industry requirement for more transparency on supplier’s quality system and supply chain. Single use suppliers are expected to better characterize their materials and processes, control the variability, understand the impact on vaccine quality and continuously improve their quality systems.

The presentation introduces an integrated supply chain and quality by design strategy whereby SUS integrators partner with polymer and film suppliers to combine material science, film extrusion and bag making expertise. These collaborations help optimize the resins and films and provide better knowledge, specifications and controls of the entire manufacturing process. This in turns allows an in depth characterization and control of extractable substances and particles profiles.

The presentation outlines how establishing resin specifications, film extrusion design spaces and quality agreements can significantly reduce raw material variability, provide consistent biocompatibility and improve product robustness and integrity. End to end process control also enhances assurance of supply and change control.



Audience take-home messages:

  • Resin specification and film design space reduce material variability and improve product quality
  • Control of raw materials and processes enhances single use product biocompatibility & integrity
  • End to end process control also improves assurance of supply and change control for single use products
17:20 - 17:50 30 mins
Info
Process Development and Characterisation Strategies
Enhanced biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing
  • Jean-Marc Cappia - Head of Segment Marketing Vaccines, Sartorius Stedim Biotech

Key objectives:

The presentation provides an overview of the challenges associated with the increasing adoption of single-use systems (SUS) in vaccines manufacturing and outlines a supply chain and quality strategy where raw material specifications and end to end process controls achieve more consistent biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing.

Bas du formulaire


Abstract

Vaccines manufacturing processes are diverse and complex and require strong commitment to quality for every raw materials and process equipment. With single becoming mainstream technology in commercial manufacture of modern vaccines, there is an increasing reliance on supplier quality and growing regulatory and industry requirement for more transparency on supplier’s quality system and supply chain. Single use suppliers are expected to better characterize their materials and processes, control the variability, understand the impact on vaccine quality and continuously improve their quality systems.

The presentation introduces an integrated supply chain and quality by design strategy whereby SUS integrators partner with polymer and film suppliers to combine material science, film extrusion and bag making expertise. These collaborations help optimize the resins and films and provide better knowledge, specifications and controls of the entire manufacturing process. This in turns allows an in depth characterization and control of extractable substances and particles profiles.

The presentation outlines how establishing resin specifications, film extrusion design spaces and quality agreements can significantly reduce raw material variability, provide consistent biocompatibility and improve product robustness and integrity. End to end process control also enhances assurance of supply and change control.



Audience take-home messages:

  • Resin specification and film design space reduce material variability and improve product quality
  • Control of raw materials and processes enhances single use product biocompatibility & integrity
  • End to end process control also improves assurance of supply and change control for single use products
17:20 - 17:50 30 mins
Info
Bioprocess Analytics and Control Strategies
Enhanced biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing
  • Jean-Marc Cappia - Head of Segment Marketing Vaccines, Sartorius Stedim Biotech

Key objectives:

The presentation provides an overview of the challenges associated with the increasing adoption of single-use systems (SUS) in vaccines manufacturing and outlines a supply chain and quality strategy where raw material specifications and end to end process controls achieve more consistent biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing.

Bas du formulaire


Abstract

Vaccines manufacturing processes are diverse and complex and require strong commitment to quality for every raw materials and process equipment. With single becoming mainstream technology in commercial manufacture of modern vaccines, there is an increasing reliance on supplier quality and growing regulatory and industry requirement for more transparency on supplier’s quality system and supply chain. Single use suppliers are expected to better characterize their materials and processes, control the variability, understand the impact on vaccine quality and continuously improve their quality systems.

The presentation introduces an integrated supply chain and quality by design strategy whereby SUS integrators partner with polymer and film suppliers to combine material science, film extrusion and bag making expertise. These collaborations help optimize the resins and films and provide better knowledge, specifications and controls of the entire manufacturing process. This in turns allows an in depth characterization and control of extractable substances and particles profiles.

The presentation outlines how establishing resin specifications, film extrusion design spaces and quality agreements can significantly reduce raw material variability, provide consistent biocompatibility and improve product robustness and integrity. End to end process control also enhances assurance of supply and change control.



Audience take-home messages:

  • Resin specification and film design space reduce material variability and improve product quality
  • Control of raw materials and processes enhances single use product biocompatibility & integrity
  • End to end process control also improves assurance of supply and change control for single use products
17:20 - 17:50 30 mins
Info
Vaccines
Enhanced biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing
  • Jean-Marc Cappia - Head of Segment Marketing Vaccines, Sartorius Stedim Biotech

Key objectives:

The presentation provides an overview of the challenges associated with the increasing adoption of single-use systems (SUS) in vaccines manufacturing and outlines a supply chain and quality strategy where raw material specifications and end to end process controls achieve more consistent biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing.

Bas du formulaire


Abstract

Vaccines manufacturing processes are diverse and complex and require strong commitment to quality for every raw materials and process equipment. With single becoming mainstream technology in commercial manufacture of modern vaccines, there is an increasing reliance on supplier quality and growing regulatory and industry requirement for more transparency on supplier’s quality system and supply chain. Single use suppliers are expected to better characterize their materials and processes, control the variability, understand the impact on vaccine quality and continuously improve their quality systems.

The presentation introduces an integrated supply chain and quality by design strategy whereby SUS integrators partner with polymer and film suppliers to combine material science, film extrusion and bag making expertise. These collaborations help optimize the resins and films and provide better knowledge, specifications and controls of the entire manufacturing process. This in turns allows an in depth characterization and control of extractable substances and particles profiles.

The presentation outlines how establishing resin specifications, film extrusion design spaces and quality agreements can significantly reduce raw material variability, provide consistent biocompatibility and improve product robustness and integrity. End to end process control also enhances assurance of supply and change control.



Audience take-home messages:

  • Resin specification and film design space reduce material variability and improve product quality
  • Control of raw materials and processes enhances single use product biocompatibility & integrity
  • End to end process control also improves assurance of supply and change control for single use products
17:20 - 17:50 30 mins
Info
Viral Safety
Enhanced biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing
  • Jean-Marc Cappia - Head of Segment Marketing Vaccines, Sartorius Stedim Biotech

Key objectives:

The presentation provides an overview of the challenges associated with the increasing adoption of single-use systems (SUS) in vaccines manufacturing and outlines a supply chain and quality strategy where raw material specifications and end to end process controls achieve more consistent biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing.

Bas du formulaire


Abstract

Vaccines manufacturing processes are diverse and complex and require strong commitment to quality for every raw materials and process equipment. With single becoming mainstream technology in commercial manufacture of modern vaccines, there is an increasing reliance on supplier quality and growing regulatory and industry requirement for more transparency on supplier’s quality system and supply chain. Single use suppliers are expected to better characterize their materials and processes, control the variability, understand the impact on vaccine quality and continuously improve their quality systems.

The presentation introduces an integrated supply chain and quality by design strategy whereby SUS integrators partner with polymer and film suppliers to combine material science, film extrusion and bag making expertise. These collaborations help optimize the resins and films and provide better knowledge, specifications and controls of the entire manufacturing process. This in turns allows an in depth characterization and control of extractable substances and particles profiles.

The presentation outlines how establishing resin specifications, film extrusion design spaces and quality agreements can significantly reduce raw material variability, provide consistent biocompatibility and improve product robustness and integrity. End to end process control also enhances assurance of supply and change control.



Audience take-home messages:

  • Resin specification and film design space reduce material variability and improve product quality
  • Control of raw materials and processes enhances single use product biocompatibility & integrity
  • End to end process control also improves assurance of supply and change control for single use products
17:20 - 17:50 30 mins
Info
Cell Line Development & Engineering
Enhanced biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing
  • Jean-Marc Cappia - Head of Segment Marketing Vaccines, Sartorius Stedim Biotech

Key objectives:

The presentation provides an overview of the challenges associated with the increasing adoption of single-use systems (SUS) in vaccines manufacturing and outlines a supply chain and quality strategy where raw material specifications and end to end process controls achieve more consistent biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing.

Bas du formulaire


Abstract

Vaccines manufacturing processes are diverse and complex and require strong commitment to quality for every raw materials and process equipment. With single becoming mainstream technology in commercial manufacture of modern vaccines, there is an increasing reliance on supplier quality and growing regulatory and industry requirement for more transparency on supplier’s quality system and supply chain. Single use suppliers are expected to better characterize their materials and processes, control the variability, understand the impact on vaccine quality and continuously improve their quality systems.

The presentation introduces an integrated supply chain and quality by design strategy whereby SUS integrators partner with polymer and film suppliers to combine material science, film extrusion and bag making expertise. These collaborations help optimize the resins and films and provide better knowledge, specifications and controls of the entire manufacturing process. This in turns allows an in depth characterization and control of extractable substances and particles profiles.

The presentation outlines how establishing resin specifications, film extrusion design spaces and quality agreements can significantly reduce raw material variability, provide consistent biocompatibility and improve product robustness and integrity. End to end process control also enhances assurance of supply and change control.



Audience take-home messages:

  • Resin specification and film design space reduce material variability and improve product quality
  • Control of raw materials and processes enhances single use product biocompatibility & integrity
  • End to end process control also improves assurance of supply and change control for single use products
17:50 - 19:20 90 mins
End of Conference Day Two and Evening Party