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Viral Clearance Strategies for Biopharmaceuticals and Cell & Gene Therapies

28 & 29 May 2025 | Short Online Course

Original price was: £595.00.Current price is: £476.00.

(1 customer review)

2-day Live Online Training 

Build effective strategies and techniques to remove or inactivate potential viruses your bioprocesses

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Enrol before 9 May to save 20% (May 2025 Course)

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

Viral contamination poses a risk to all animal- and human-derived biopharmaceuticals. This type of contamination can impact any stage of the bioproduction process, so process scientists must conduct viral testing studies and integrate viral clearance strategies into their processes.

 

This short live online training course will enable you to understand the risk and impact of viral contamination in biopharmaceutical manufacturing. You will review the viral contamination and clearance guidance such as ICH Q5A to ensure your products comply. As well as risk prevention, you will examine in-depth viral clearance strategies and studies. Once completed, you will know what studies are required and when during CMC development to demonstrate safe viral inactivation and removal.

 

The course will examine cell banking for biopharmaceuticals, as well as particularities for cell & gene therapies and bioassays. Along with the presentation, examples, case studies and a complete literature review will be provided.

 

Learn more about how we deliver live online training.

Download the Agenda

 

You can view the agenda by scrolling down on this page. If you would like to receive a PDF version with all the course information, please complete the form below.

 

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Key Learning Objectives

 

  • Appreciate the risk and impact of viral contamination in biopharmaceutical manufacturing
  • Review case study examples of viral contamination and the lessons learned that you can apply to your development processes
  • Understand the regulatory expectations on preventing the risks of viral contamination
  • Discover the specific regulatory requirements for recombinant proteins, cell therapies and gene therapies
  • Deep dive into ICH Q5A viral safety evaluation to ensure you are compliant
  • Discuss prevention strategies and processes to minimise viral contamination in your processes.
  • Gain the skills to develop effective strategies and techniques to remove or inactivate potential viruses
  • Learn how to demonstrate the capability of your process to remove or inactivate viruses effectively

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

28 & 29 May 2025

7-Hour Course Delivered Over 2-Days

Register at the top of the page.

20 & 21 November 2025

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

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered online.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)

 

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

28 May 2025

20 November 2025

 

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

29 May 2025

21 November 2025

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.

This course is aimed at professionals who work in biopharmaceutical, cell therapy or gene therapy manufacturing. It is suited to those who have an input or manage viral contamination and viral clearance.

These include:

  • Bioprocess Scientists
  • Upstream Professionals
  • Downstream Professionals
  • Bioprocess Development Personnel
  • Bioprocess Engineers
  • Production Personnel/Technicians
  • Quality

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Viral Clearance Strategies for Biopharmaceuticals and Cell & Gene Therapies

28 & 29 May 2025 | Short Online Course

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