Course Outline

Course Information

• The course begins at the time stated below
• The course is broken up into modules outlined below
• There will be breaks between modules

Session 1 | Day 1

14 November 2024

11 June 2025

8 October 2025

210 mins | 1:00 PM UK

Introduction

• Introductions and overview of the course and format

Overview of continuous biomanufacturing

• History of continuous manufacturing
• Reviewing and understanding the pros and cons of a continuous approach in biotech
• Latest technologies for large-scale production of recombinant proteins
• The necessity for flexible manufacturing processes
• The challenge of managing manufacturing costs
• The implementation of single-use systems

Upstream perfusion technologies

• Principles of various cell culture modes: batch, fed-batch, intensified fed-batch, and perfusion
• Examine cell metabolism in fed-batch vs perfusion
• How to move from batch to perfusion system:
  • Cell retention technologies
  • Continuous media feed

Downstream technologies

• Fundamentals of continuous chromatography
• Available technologies based on chromatography resins
• Continuous viral inactivation

Session 2 | Day 2

15 November 2024

12 June 2025

9 October 2025

210 mins | 1:00 PM UK

Regulatory & quality considerations for continuous biomanufacturing

• Understand the current regulatory landscape
• ICH, EU and US FDA Guidelines
• Review of ICH Q13
• Steady-state vs State-of-Control
• Understand the diversion points
• Review the limitations for biopharmaceutical processes
• Expectations for Process Analytical Technologies (PAT

Validation for continuous processes

• General principles of process validation
• Understand the key differences to classical batch processing
• Continuous process performance qualification and batch definition
• Setting-up the control strategy
• Residence time distribution
• Continuous viral clearance
• Continuous filtration
• Bioburden control

The future of continuous processing

• What are the latest purification technologies?
• Review the business case for continuous manufacturing
• Further development of Process Analytical Technologies
• Real-time of drug substance release (RTR)

Conclusion

• Wrap and summary of the course
• Questions and answer session

Mylène Talabardon – With over 20 years of experience in the pharmaceutical industry, Mylène has strong experience in process development, technology transfer and process validation. She obtained her PhD in biotechnology from The Ohio State University and her environmental engineering degree from the Swiss Federal Institute of Technology (EPFL). In 2001, she joined BiogenIdec in cell culture process department, focusing on antibody production from the lab scale to manufacturing scale. In 2004, she was appointed head of the cell culture department at Merck Serono and started working in validation according to QbD for biotechnological products. After 2 years as CMC lead for a biosimilar product, she was nominated Process Validation Expert, and in this position, she developed the Global Process Validation strategy for the company according to European and FDA regulations for pharmaceuticals and supported CMC teams in developing Process Validation plans for new biologics as well as for legacy products.

Hervé Broly – Starting with an engineering degree in agriculture, followed by a PhD in plant physiology,  Hervé joined the Blood Transfusion Center (Lille, France) in 1982 where he implemented a unit for the development and manufacture of monoclonal antibodies against blood groups, blood proteins and viral antigens. In 1991, Hervé took the position of Head of Process Development and Manufacturing at Sorebio (Martillac, France), a contract manufacturing organization specialized in the development and manufacture of monoclonal antibodies for clinical development. He took the lead of that company in 1998 after it was bought by Serono, a Swiss biotech company (Geneva, Switzerland) in 1994.

In 2003, Hervé moved to Serono in Geneva as Global Product Team Leader in charge of managing the development of a recombinant Ig-fusion protein for the treatment of autoimmune diseases, moving that product from Phase I to Phase III.

As of November 2006, Hervé has been appointed Vice-President, Head of Biotech Process Sciences at Merck-Serono, based in Vevey, Switzerland, in charge of developing and validating the manufacturing processes for biotechnological products. In that context, whereas Serono was mainly using perfusion processes for recombinant hormones and cytokines, we moved the company to large-scale manufacture of monoclonal antibodies using proprietary chemically-defined cell culture media and feeds. After our participation to the FDA’s pilot program on Quality by Design, the concepts described in ICH Q8(R2) and ICH Q11 were implemented in our approach to gain process understanding. It was concluded by issuing a modernized approach for process validation at Merck (Darmstadt, Germany). More recently, we have introduced advanced processes such as intensified fed-batch and continuous downstream processing.