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

29 & 30 April 2026 | 1 & 2 December 2026

7-Hour Course Delivered Over 2-Days
Register at the top of the page.

Session 1 | Day 1

210 mins | 1:00 PM UK

Introduction

• Introductions and overview of the course and format

Risk and impact of viral contamination in biopharmaceutical manufacturing

• Understand the risk of viral contamination and why it is critical to remove potential viruses
• Examine the biology of viruses
• Reported events
• Sources of contamination
• Impacts of viral contamination
• Review case studies of viral contamination
  • Discuss the lessons learnt

Regulatory landscape

• Review the regulatory requirements surrounding viral contamination and clearance
• Source documentation
• Analyse ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products

Examine the requirements of specific products including

• Recombinant proteins
• Gene therapies
• Cell therapies

Risk prevention

• Examine methods, processes and strategies to reduce viral contamination.
• Source of raw materials, prevention and testing
• Learn what cell bank testing is required
• Testing of process intermediates
• Discuss critical environmental controls
• Personnel control
• Segregation of manufacturing activities
• Closed processes
• Impact of the COVID pandemic

Session 2 | Day 2

210 mins | 1:00 PM UK

Viral clearance studies – part 1

• What studies are required throughout CMC development?
• When are the studies required throughout CMC development?
• Examine how to develop a viral clearance strategy
• Discuss virus inactivation and removal
  • Techniques of virus inactivation
  • Techniques of virus removal
• Viral clearance using orthogonal process steps
• Review scale-down models

Viral clearance studies – part 2

• Model viruses
• Pre-requisites to spiking studies
• Spiking studies
• Testing methods
• New and aged chromatography resins
• Virus-Like Particles (VLP) quantification
• Overall process capability to remove/inactivate viruses
• Learn how to manage viral clearance within a continuous manufacturing process

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.