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07:30 - 08:20 50 mins
Registration and Morning Coffee
08:20 - 08:30 10 mins
Chairperson's Opening Remarks
08:30 - 09:00 30 mins
Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing
  • Rahul Singhvi - Chief Operating Officer, Takeda Vaccines, Inc
09:00 - 09:30 30 mins
Future Strategies for Bioprocessing - A Representative from Pall Life Sciences
09:30 - 10:00 30 mins
Future Process Development Strategies to Improve Process Productivity and Increase Capacity
  • Judy Chou - SVP and Head of Biotech, Bayer Pharmaceuticals
10:00 - 10:30 30 mins
Next Generation Process Development – Platforms, Plants and Products
10:30 - 11:15 45 mins
Morning Coffee and Networking
11:15 - 11:45 30 mins
From Early Stage to Late Stage Development: How to Characterise a Perfusion-based Vaccine Production Process using QbD?
  • Sarah Mercier - Scientist USP, Janssen, Pharmaceutical Companies of Johnson and Johnson

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

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

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

11:45 - 12:15 30 mins
Computational fluid dynamics modeling for fermentation risk reduction during technology transfer and process understanding
  • Tracie Sprangler - Associate Principal Scientist, Engineering, Merck & Co., Inc., USA

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

12:15 - 12:45 30 mins
Automated Determination of Viral Particle Yield, Purity, Size and Integrity in Downstream Process Development
  • Mathieu Colomb-Delsuc, Ph.D. - Senior Scientist, Electron Microscopy Technologies, Vironova

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

12:45 - 14:00 75 mins
Lunch in the Exhibition Hall and Live Labs
14:00 - 14:30 30 mins
Process Development Strategies for Viral Vectors used in Gene Therapy
  • Franz Gerner - Senior Director Process Development, REGENXBIO Inc., USA

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

14:30 - 15:00 30 mins
Process Development of Retroviral Vectors for CAR-T Cell Therapies
  • Paulo Fernandes - Senior Scientist, Autolus

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

15:00 - 15:30 30 mins
Spotlight presentation
15:30 - 16:00 30 mins
Afternoon Coffee Break
16:00 - 16:30 30 mins
Development of Vaxwave® and TheraT® viral vectors for active immunization against infectious diseases and cancer
  • Anders Lilja - VP Technical Development, Hookipa Biotech, Austria
16:30 - 17:00 30 mins
Adenovirus vector-based expression of antigens towards vaccine development
  • Santosh K Nanda - Interdisciplinary Scientist, FDA/CBER, USA (awaiting final confirmation)
17:00 - 17:10 10 mins
Plenary Changeover
17:10 - 17:40 30 mins
Closing Plenary - Sartorius
17:40 - 19:40 120 mins
End of Conference Day One and Evening Entertainment