Informa
09:00 - 09:40

Registration and Morning Coffee

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Showing of Streams
11:20 - 12:10

Morning Coffee Break and Networking

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Showing of Streams
14:10 - 15:30

Lunch and Networking

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Showing of Streams
17:00 - 17:30
Info

Industry 4.0 in Aviation - Digitalization without beta versions

Topics like Digitalization and Industry 4.0 are currently on everyone's minds. New economy companies revolutionizing more and more classical business models. Aviation, like other safety sensitive industries, is working hard to keep up. Unlike services from the big role models out of e.g. Silicon Valley, aerospace products cannot and will not shipped in Beta status. This presentation will show examples how Lufthansa is addressing these challenges.

  • Sven Taubert - Head of Corporate Foresight & Market Intelligence, Lufthansa Technik AG
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17:30 - 19:30

Opening of Exhibition Hall & Networking Drinks

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19:30 - 19:35
End of Conference Day One

End of Conference Day One

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09:00 - 09:40 40 mins
Registration and Morning Coffee
09:40 - 09:50 10 mins
Cell Culture and Upstream Process Development
Chairperson's opening Remarks
  • Swapnil Bhargava - Sr. Director and Head of the Department BioProcess Development, Seattle Genetics, Inc.
09:40 - 09:50 10 mins
Downstream Processing
Chairperon's Opening Remarks
09:40 - 09:50 10 mins
Vaccines
Chairperson's Opening Remarks
09:40 - 09:50 10 mins
Raw Materials
Chairperson's Opening Remarks
09:40 - 09:50 10 mins
Cell Line Development & Engineering
Chairperson's Opening Remarks
09:50 - 10:20 30 mins
Cell Culture and Upstream Process Development
Optimisation of Perfusion Processing to Increase Process Intensity and Manufacturing Capacity
  • Steffen Kreye - Upstream Process Development Expert, Bayer
09:50 - 10:20 30 mins
Downstream Processing
Computational Fluid Dynamics and Nanoscale Modelling of Process Chromatography: Towards a Virtual Bioprocess?
  • Alois Jungbauer - Professor, BOKU & Austrian Centre of Industrial Bio
09:50 - 10:20 30 mins
Info
Vaccines
Scalable manufacturing Adenoviral vectors platform technology
  • Qian Ruan, Ph.D - Senior Director of Process Development and Production, Emergent Biosolutions, USA

Adenoviruses’ ability to be easily genetically modified, their excellent safety profiles, broad tissue tropism, and ability to drive robust, sustained transgene expression made them an excellent platform technology.   PaxVax has been using the safety data of military Ad4/Ad7 and developed an adenovirus platform technology for various vaccines (such as HIV, anthrax, H5N1 flu etc.). PaxVax generated Ad4 and Ad7 based viral vectors in fully GMP characterized A549 cell lines. The developed scalable, disposable platform technology uses serum free suspension A549 cells, expanded in disposable bioreactor, purified with disposable membrane chromatography. The products are either in liquid form for intranasal clinical studies or coated capsules form for the gut delivery.

09:50 - 10:20 30 mins
Raw Materials
Hot topics and challenges in raw materials for biologicals
  • Dominic Moore - Director, QC Raw Materials, Sanofi Genzyme
09:50 - 10:20 30 mins
Cell Line Development & Engineering
Overcoming the Challenges of Cell Line Development and Engineering for Difficult to Express Proteins
  • Martin Gamer - Associate Director, Early Stage Bioprocess Development, Boehringer Ingelheim Pharma GmbH & Co. KG
10:20 - 10:50 30 mins
Cell Culture and Upstream Process Development
Process Intensification: Focus on N-1 Perfusion in Routine Manufacturing
  • Daniel Karst, PhD - Mfg Scientist, Global Manufacturing Sciences, Biogen International GmbH
10:20 - 10:50 30 mins
Downstream Processing
Tomorrow’s Gene Therapy Manufacturing
  • Laurence Croute, MSc - Senior Scientist, Technical Development, New Biological Entities, Novartis
10:20 - 10:50 30 mins
Info
Vaccines
Challenges in the advancement of Vaccine manufacturing in Developing Countries
  • Lakshmi Khandke - Program Advisor, PATH

There are major challenges in developing vaccines particularly multivalent, due to their manufacturing complexity which include the cost, facilities, technology transfer, regulatory guidance, implementation and sustainability from clinical development to commercial manufacturing.  With an emphasis on developing country vaccine manufacturers and transfer of technology, this presentation describes strategies and approaches to better understand and characterize vaccines using a broad analytical tool-kit for development and transferring robust processes.

10:20 - 10:50 30 mins
Raw Materials
Upstream Viral Risk Mitigation Strategy for High Titer Biologics Manufacturing
  • Dave Kolwyck - Director Manufacturing Science - Raw Materials, Biogen Idec, USA
10:20 - 10:50 30 mins
Cell Line Development & Engineering
Cell Line Development Strategies for Bispecific and Multi-Specific Proteins
  • Valentina Ciccarone, Ph.D. - Principal Scientist, Cell Line Development, MacroGenics, Inc.
10:50 - 11:20 30 mins
Info
Cell Culture and Upstream Process Development
Enhancing Single-Use Bioreactors Equipment for Scale-Up and Flexible Facilities
  • Geoffroy Malherbe - Single-Use Technologies Business Development, Thermo Fisher Scientific

This presentation will illuminate application specific tools, best practices, and recommendations that best leverage strategic enhancements to the sparge and agitation systems thereby resulting in process impacts of >50% improvement to mixing & mass transfer performance compared to legacy SUB designs. The results of these improvements yield new system characterization models and application data showing benefits of 50L, 100L, 250L, and 500L S.U.B. including culture results. Reliability and consistency of results were further improved by including single use conductivity based foam probes (simple to implement and especially resistant to foam fouling effects). Furthermore these enhancements have been fine tuned into 3 different application specific SUB configurations for animal cell culture scale-up optimization well suited for CHO platforms of fed-batch and perfusion as well as VERO cells grown on micro-carriers. The ending deliverable is a generous expansion of bioreactor capabilities for new SUB equipment and many SUBs already installed in existing facilities.

10:50 - 11:20 30 mins
Downstream Processing
Spotlight Presentation
  • Marc Hogreve - Senior Engineer Integrity Testing, Sartorius Stedim Biotech
10:50 - 11:20 30 mins
Info
Vaccines
Outsource manufacturing of your vaccine candidate: the do’s and the don’ts.
  • Nicole Peuker - Principal Expert Upstream Development, Affiliation Wacker Biotech

How to translate a product idea into a GMP manufactured product? Wacker Biotech is a contract manufacturing organization with broad experience in development and GMP manufacturing activities of vaccines and other microbial products. Wacker Biotech will share experiences and approaches from various vaccine products, including considerations for process development.

10:50 - 11:20 30 mins
Raw Materials
Spotlight Presentation - GE
10:50 - 11:20 30 mins
Info
Cell Line Development & Engineering
Speeding Up HEK 293 Cell Line Development for Upstream Production of Viral Vectors
  • Sophie Broussau - Cell Line Development Specialist, NRC-Montreal

Mammalian cell platform offer many advantages for viral vector and VLP production. Adapted to grow in suspension culture and in serum-free medium, HEK293 can be expanded for large-scale production. Inducible stable producer cell lines can be developed and performer clones can be isolated using the CellCelector single cell cloning system with a novel nanowell technology. An efficient method designed to isolate clones of packaging cells for lentiviral vectors will be described.

11:20 - 12:10 50 mins
Morning Coffee Break and Networking
12:10 - 12:40 30 mins
Info
Cell Culture and Upstream Process Development
Integrated Modelling Methodology to Accelerate Fed-Batch and Perfusion Process Development
  • Ben Yahia Bassem - UPS Scientist, UCB Pharma S.A. - Bioscience

The acceleration of biopharmaceutical process development is difficult when traditional experience-based sequential approaches are used. As a result, fully optimized and well understood cell culture processes prior to scale-up are rare. Here we show that an accurate, scalable and simple model able to predict cell growth, cell metabolism, titer and some product quality attributes will significantly accelerate process development, improve process development outcomes and reduce development and production costs. We will present a simple systematic modeling methodology to study and predict fed-batch cell culture performance. We will also show that this approach can be applied to the optimization of perfusion processes. Only a limited number of parameters need to be identified based on experimental results, which means that for each production process to be modeled, a minimal number of small scale bioreactor runs need to be performed before switching to in silico process development. We will show that this approach can accurately predict process performance both at small and large scale. Furthermore, various feeding strategies could be tested and optimized in silico.

In a second step, the model was extended and applied to critical product quality attributes such as charge variants. This modeling approach shed further light on the impact of the feeding strategy on product quality. For instance, we will show that the total quantity of specific metabolites used throughout the bioreactor production process controls charge variants distribution, whereas within a given concentration range the daily concentration of these same metabolites is not predictive.

Finally, the model was also applied to the development of continuous and hybrid/intensified production processes. The perfusion rate was controlled daily using the model calibrated with fed-batch production data.

In summary, our modeling methodology provides a much better insight into the impact of process parameters on production yields and product quality, thus improving process understanding and control as well as accelerating process development. A user friendly app was developed in house in order to share internally the model and to apply it to multiple CMC projects for process development.

12:10 - 12:40 30 mins
Downstream Processing
Utilizing Modelling for Downstream Process Development
12:10 - 12:40 30 mins
Vaccines
Generation and Production of Modified Vaccinia Virus Ankara (MVA) as a Vaccine Vector
  • Alexander (Sandy) Douglas - Principal Investigator, Nuffield Department of Medicine, University of Oxford
12:10 - 12:40 30 mins
Raw Materials
Feedback from the ISIA on the use of serum in manufacturing
  • Rosemary Versteegen, PhD - CEO, International Serum Industry Association
12:10 - 12:40 30 mins
Info
Cell Line Development & Engineering
Highlights from the process development of GBR 310, Glenmark’s biosimilar for
  • Martin Bertschinger - Deputy Director Cell Sciences, Glenmark Pharmaceuticals SA.

Glenmark’s biosimilar of Xolair (omalizumab), GBR 310, is currently under clinical evaluation. The development of a process for manufacturing of a biosimilar molecule is highly challenging, as critical quality attributes are influenced by multiple factors (in particular by the cell line development process and the upstream process). For the development of GBR 310, Glenmark has developed a strategy that allowed the manufacturing of omalizumab matching a quality target profile pre-defined by the Innovator molecule Xolair.

12:40 - 13:10 30 mins
Cell Culture and Upstream Process Development
Scaled Down Perfusion Processes
  • Meghan Casey - Process Development Engineer III, Regeneron Pharmaceuticals, Inc.
12:40 - 13:10 30 mins
Downstream Processing
Data Structure, Modeling and Knowledge Management in Process Development for Smooth and Efficient BLAs
  • Dr. Joey Studts - Global BioProcess & Pharmac. Dev, Boehringer Ingelheim Pharma GmbH & Co. KG
12:40 - 13:10 30 mins
Info
Vaccines
High Titre Stable Suspension Lentiviral Vector Producer Cell Lines Using Bacterial Artificial Chromosome (BAC)
  • Mark (Mao Xiang) Chen - Manager, Cell Line Development, Cell and Gene Therapy CMC,, GlaxoSmithKline R&D

Lentiviral vectors are showing success as delivery vehicles for gene therapy, however, suppling sufficient quantities of clinical grade vectors remains challenging. To overcome some of the limitations of current 4 plasmids transient transfections GSK has established a technology to produce stable lentiviral vector producer cell lines from a single large BAC construct, and manufacture in suspension culture in large bioreactors.

12:40 - 13:10 30 mins
Raw Materials
Spectroscopic online monitoring methods to identify the impact of preparation parameters and raw materials on chemically defined cell culture media quality
  • Andreas Unsold - Head of Cell Culture Media, Boehringer Ingelheim
12:40 - 13:10 30 mins
Info
Cell Line Development & Engineering
High Titre Stable Suspension Lentiviral Vector Producer Cell Lines Using Bacterial Artificial Chromosome (BAC)
  • Mark (Mao Xiang) Chen - Manager, Cell Line Development, Cell and Gene Therapy CMC,, GlaxoSmithKline R&D

Lentiviral vectors are showing success as delivery vehicles for gene therapy, however, suppling sufficient quantities of clinical grade vectors remains challenging. To overcome some of the limitations of current 4 plasmids transient transfections GSK has established a technology to produce stable lentiviral vector producer cell lines from a single large BAC construct, and manufacture in suspension culture in large bioreactors.

13:10 - 13:40 30 mins
Cell Culture and Upstream Process Development
Comparison Of Perfusion Systems At Seed Stage (n-1)
  • Ruchika Bandekar - Associate Scientist II, Medimmune
13:10 - 13:40 30 mins
Downstream Processing
Utilizing Data Science and PAT Tools for Decision Making in the Bioprocess Life Cycle
  • Christoph Herwig, Ph.D - Professor, Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
13:10 - 13:40 30 mins
Info
Vaccines
Rapid HeLa based Producer Cell Line Development for Scalable rAAV Production
  • Aubrey R Tiernan - Senior Scientist, Head of Cell Line Development, Ultragenyx Pharmaceuticals, Inc

One challenge for cell line development in industry is to generate highly productive stable cell lines within the shortest time frame possible.  This presentation will cover lessons learned over three years in establishing a robust, high throughput HeLa suspension screening platform to generate stable monoclonal producer cell lines suitable for Phase III clinical trial/commercial rAAV production.

13:10 - 13:40 30 mins
Info
Raw Materials
Utilizing the Joint Audit Approach for Single Use Systems
  • Jim Fries - CEO, RX-360

Background:

The BioPhorum Group in conjunction with Rx-360 have identified the current value of joint audits throughout the industry.  In an effort to bring the joint audit model to single use systems.  The purpose of the pilot is to validate the joint audit model within the auditing process of single use systems.  Through this Pilot BPOG and Rx-360 will also be able to validate best practices around cost effect, quality based joint audits and the alleviation of supplier burden during the audit process.


Methods:

Rx-360 and BioPhorum will utilize BSI to conduct the audits that are scheduled within the Pilot.  The Pilot is being driven by a Steering Committee that is made up of members of all three organizations.  Those members will collaboratively drive the Pilot planning stage through analysis of data, and implementation of best practices or improvements.  The Pilot will identify “Reviewers” who will take on the traditional role of cosponsors of the audit, as described within the current Joint Audit Model.  The Pilot will be made up of 12 audits that will be broken up into 4 “sprints or sections of 3 audits each.  Key measures that will be tracked during Pilot are:

  • The delivery of final audit report within 30 business days
  • The number of times a completed audit is licensed
  • CAPA compliance (20 days)
  • Reduction in supplier audit burden as measured by planning time, hosting time, responding to and reviewing multiple audits and all associated costs.
  • Survey feedback from participants
  • Observations identified during Pilot as categorized as Potentially Critical and/or Other.


Outcome of Pilot:

Upon completion of the Pilot, a collaborative team identified by Rx-360 and BioPhorum will write a consensus paper (to be published) that will provide the results, and data of the Pilot. 


Presentation Goal:

To provide an Overview of entire program and for the first time publicly present results of the initial phase of the Pilot.

13:10 - 13:40 30 mins
Info
Cell Line Development & Engineering
Rapid HeLa based Producer Cell Line Development for Scalable rAAV Production
  • Aubrey R Tiernan - Senior Scientist, Head of Cell Line Development, Ultragenyx Pharmaceuticals, Inc

One challenge for cell line development in industry is to generate highly productive stable cell lines within the shortest time frame possible.  This presentation will cover lessons learned over three years in establishing a robust, high throughput HeLa suspension screening platform to generate stable monoclonal producer cell lines suitable for Phase III clinical trial/commercial rAAV production.

13:40 - 14:10 30 mins
Cell Culture and Upstream Process Development
Spotlight Presentation from Merck
13:40 - 13:55 15 mins
Downstream Processing
Spotlight Presentation from Parker
13:40 - 14:10 30 mins
Info
Vaccines
Scalable Adenovirus production process, from cell culture to purified bulk
  • Mats Lundgren - Customer Applications Director , GE Healthcare

Adenovirus (AdV) vectors are commonly used in cancer gene therapy trials, evaluated in gene therapy and used as vaccines for various diseases. AdV vectors are well studied and are suitable for vaccines, oncolytic and gene therapy due to their ability to infect different cell types, remain episomal and produce stable high titer material. Manufacturing of safe and efficacious clinical-grade virus relies on a scalable and cost-effective production process. In this study, we have combined experimental work and process economy calculations, from AdV production in cell culture to purified bulk product up to 10L scale. An efficient and scalable process for AdV production was developed by evaluation and optimization of each process step. The most studied vector is serotype 5, making this a suitable system for process development of AdV vectors. Human AdV5 expressing the green fluorescent protein (GFP) was used for process development. First, suspension HEK 293 cells adapted to serum-free cell culture medium were optimized for AdV production and evaluated in different single use bioreactor systems. Tween 20 was used for cell lysis as a replacement for the traditionally used Triton X-100 (now on the Authorization list (Annex XIV) of REACH, the regulation on Registration, Evaluation, Authorization and restriction of Chemicals). A residual Tween 20 assay with low detection limit was set-up. Filters and conditions for clarification, concentration and buffer exchange by tangential flow filtration were optimized. Anion exchange based capture step alternatives were compared, including different chromatography resins and membrane formats. Finally, core bead technology was evaluated as an alternative to size exclusion chromatography for the polishing step before the formulation into storage buffer. Analytical methods for virus titer are challenging and depend on purity and quality of the sample. For total virus titer, qPCR and HPLC methods were used. Furthermore, assays based on surface plasmon resonance (Biacore) was developed for analysis of adenovirus titer. For infectious virus titer, we have used a cell based assay with automatic image analysis. Based on analytical data different downstream process alternatives were compared regarding load capacity, recovery and purity and we propose a robust and scalable process with a favorable process economy.

13:40 - 14:10 30 mins
Raw Materials
Spotlight presentation
13:40 - 14:10 30 mins
Cell Line Development & Engineering
Novel Approaches and Technology Implementation to Demonstrate Assurance of Clonality
  • A Representative from Cytena, Cytena
13:55 - 14:10 15 mins
Downstream Processing
Spotlight Presentation from Repligen
14:10 - 15:30 80 mins
Lunch and Networking
15:30 - 16:00 30 mins
Cell Culture and Upstream Process Development
Integrated Media Blending Increases Efficiency of Clone Selection
  • Dr. David Bruehlmann, Ph.D - Manager, Biotech Process Sciences Technology & Innovation, Merck
15:30 - 16:00 30 mins
Downstream Processing
Advanced Control using Process Analytics for Purification and Particle Engineering
  • Dylan Jones - Development Lead, Sanofi
15:30 - 17:00 90 mins
Info
Vaccines
Tri Dialogue: Process Development - Platform Processes for Increased Efficiency and Reduced Risk
  • Yan-Ping Yang - Head of BioProcess Research & Development, Sanofi
  • Dieter Palmberger - Senior Scientist, acib - Austrian Centre of Industrial Biotechnology
  • Amish Patel - Senior Director, Product Development, Emergent Biosolutions, USA

Talk One: Recent challenges and opportunities in Downstream processing

Confirmed speaker: Yan-Ping Yang, Head of Bioprocess Research & Development, North America, Sanofi Pasteur

Talk 2: Process development for a flexible vaccine vector platform based on recombinant life virus

Confirmed speaker: Dieter Palmberger, Senior Scientist, acib - Austrian Centre of Industrial Biotechnology, Austria

Talk 3: Development of different delivery platforms for Biologics

  • Unlike conventional formulation development, delivery platform and late stage formulation focus more on the control of delivery technology for dosage forms. Conditions to keep the desired potency of drug/biologic before and during the administration is equally important.
  • Poor delivery platform will causes significant potency loss of drug/biologic during the administration no matter how great of shelf-life the product has.
  • Scientists working in the formulation field should consider the delivery route as a critical factor in developing their product and design the formulation and delivery study to support it or could see failure in the animal study, clinical study and impact the future of the project

Confirmed speaker: Amish Patel, Senior Director, Product Development, PaxVax, USA

15:30 - 16:00 30 mins
Raw Materials
Sourcing strategies - quality audits and vendor oversight
15:30 - 16:00 30 mins
Info
Cell Line Development & Engineering
Accelerating Cell Line Development using Transposase-Mediated Integration and Verified In-Situ Plate Seeding
  • Angela Tuckowski - Associate Scientist, Janssen R&D Cell & Developability Sciences Group

The Janssen R&D Cell Line Development group has partnered with ATUM to evaluate their transposase-mediated integration system, which allows us to generate higher producing transfection pools and limit the need for downstream screening.  We have also partnered with Solentim to evaluate their Verified In-Situ Plate Seeding (VIPS) system, which allows us to seed and image single cells in microtiter plates to assure monoclonality in a single imaging step. These additions have resulted in a more efficient and accelerated cell line development process.

16:00 - 16:30 30 mins
Cell Culture and Upstream Process Development
Bioprocess Intensification for the Continuous Expansion of Pluripotent Stem Cells
  • Paula Alves, Ph.D - CEO, Director, Animal Cell Technology Unit., iBET
16:00 - 16:30 30 mins
Downstream Processing
Topic to be Determined
  • Anna Senczuk, MSc - Senior Process Engineer II, Shire
16:00 - 17:00 60 mins
Raw Materials
End of day Q&A/ Session wrap up
16:00 - 16:30 30 mins
Info
Cell Line Development & Engineering
Cytena Single Cell Printer: Getting from Implementation to Robust Cloning Process
  • Kerensa Klottrup-Rees - Scientist II, Cell Culture and Fermentation Sciences, MedImmune

Integrating a new technology is never a simple switch, it impacts the whole workflow. Here we share how we took on the process of optimising many aspects around the introduction of the Cytena Single Cell Printer for single cell cloning to ensure we were able to robustly deliver cell lines for a range of molecules from the portfolio.

16:30 - 17:00 30 mins
Cell Culture and Upstream Process Development
Full Line Integrated Continuous Process from Upstream to Downstream
  • Karen Wen, PhD - President, Mycenax Biotech Inc.
16:30 - 17:00 30 mins
Downstream Processing
Full Line Integrated Continuous Process from Upstream to Downstream
  • Karen Wen, PhD - President, Mycenax Biotech Inc.
16:30 - 17:00 30 mins
Info
Cell Line Development & Engineering
Panel Discussion: Strategies to Evaluate and Improve Cell Line Stability
  • What things affect cell line and clone stability?
  • How to use information on genome stability to produce more stable cell lines?
  • Strategies to evaluate long term cell line stability
  • Development of predictive models for cell line stability assessment in early stage development
  • New technologies to predict clone stability
17:00 - 17:30 30 mins
Info
Industry 4.0 in Aviation - Digitalization without beta versions
  • Sven Taubert - Head of Corporate Foresight & Market Intelligence, Lufthansa Technik AG

Topics like Digitalization and Industry 4.0 are currently on everyone's minds. New economy companies revolutionizing more and more classical business models. Aviation, like other safety sensitive industries, is working hard to keep up. Unlike services from the big role models out of e.g. Silicon Valley, aerospace products cannot and will not shipped in Beta status. This presentation will show examples how Lufthansa is addressing these challenges.

17:30 - 19:30 120 mins
Opening of Exhibition Hall & Networking Drinks
19:30 - 19:35 5 mins
End of Conference Day One

* 活動內容有可能不事先告知作更動及調整。