Vaccines development, regulations and manufacturing Part-1
This two-part webinar will focus on vaccines and an overview of their science, technology and, manufacturing processes. In Part 1, we will focus on the timelines and organizations involved, regulatory, quality and safety testing, and the different components and activities that contribute to their development including, antigens and adjuvants. The strategies and different philosophies which facilitate process optimization and scale-up, such as QbD and how the cost of a vaccine is assessed will also be studied.
Stephen W. Brown, PhD
Stephen is a consultant based in France with 40 years experience in the biopharmaceutical industry. Formerly, he was Executive Director, BE Vaccines, Nantes, France, and IPV Project Champion for the parent company, Biological E Ltd, Hyderabad, India. Steve holds a BSc in Microbiology from University of Cardiff and a PhD in Fermentation Technology from University of Kent at Canterbury, UK. His Postdoctoral was at the Institut für Biotechnologie, ETH Zurich, Switzerland.
Steve’s career has focused on human and animal vaccines and gene medicines product development including, process development, GMP manufacturing, site management, manufacturing facility design and construction, Single-use Technology implementation and exploitation and partnership management. Prior to joining Biological E. Ltd, he previously worked at, G.D Searle (UK) and Transgene, Merial and Vivalis/Valneva (USA/France). Steve is a member of PDA, ISPE and ASTM and joint author of PDA SUS TR66. He was previously a board member of the Bio-Process Systems Alliance and Co-Chair of BPSA's European Advisory Council.
VP Technical Communication & Regulatory Strategy
Helene has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in manufacturing, quality and regulatory aspects. She has over 30 years of experience working for the biopharmaceutical industry, the last 29 years within Pall Corporation. She speaks regularly at conferences about single-use technology with a strong focus on validation and overall process integration aspects. She is also involved in different industry interested group with a strong focus on BPOG, and she is sitting on the board of BPSA.
Vaccine Production: Securing process quality with flexible manufacturing solutions
Pall’s innovative process technologies have been an important contributor to the success of many vaccine production processes, and we are constantly working with the industry to enhance our solutions to meet new vaccine development and manufacturing challenges.
In 2019 Swissfillon were inspected and approved by the FDA to supply drug products into the USA, following on from EU approval in 2018. This young fill finish CMO was started in Switzerland in 2013 and built a state-of-the-art cGMP production facility from the ground up.
Swissfillon recognized early on that single-use systems met their requirements for multi-product manufacturing and would help their clients get their drugs to market faster.
During this case-study webinar, participants will learn:
- How working in partnership with a supplier can be part of a QbD approach to minimize risk
- Strategies & design improvements for single-use systems to reduce risk in the process
- How a shadowboard can be used to make single-use system leak tests, PUPSIT and the filtration process fast, safe and simple