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2-day Live Online TrainingÂ
Implement continuous processes for biopharmaceutical manufacturing to improve quality, time and reduce costs
Discount has been applied to the price above. VAT, if applicable, will be added.
Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.
Continuous biomanufacturing has the potential to improve product quality, costs and speed up time to market. In addition to the advantages there are also challenges that must be overcome when implementing continuous bioprocessing. These include regulatory considerations, adapted technologies, development steps and validation.
This short live online training course will enable you to understand the fundamentals of implementing a continuous manufacturing approach for unit operations, upstream and downstream processing. During the course, you will review the regulatory and quality framework for continuous bioprocessing to ensure you are compliant. You will assess major steps to develop a continuous approach as well as practical guidance for monitoring, controlling and validating continuous bioprocessing.
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.
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
7-Hour Course Delivered Over 2-Days
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7-Hour Course Delivered Over 2-Days
Register at the top of the page.
1-Day Live Online Training
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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.
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.
Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)
Course Information
14 November 2024
11 June 2025
8 October 2025
210 mins | 1:00 PM UK
Introduction
Overview of continuous biomanufacturing
Upstream perfusion technologies
Downstream technologies
15 November 2024
12 June 2025
9 October 2025
210 mins | 1:00 PM UK
Regulatory & quality considerations for continuous biomanufacturing
Validation for continuous processes
The future of continuous processing
Conclusion
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 manufacturing. It is suited to those who currently operate a continuous process or for those who are considering a continuous approach. These include:
Educo Life Sciences –
This is a new course – Reviews will be added after the first delivery!