Annex 1 of the European Union's (EU) Good Manufacturing Practice (GMP) guidelines emphasizes the importance of closed system processing in pharmaceutical manufacturing, by accomplishing material transfer via aseptic connections of auxiliary materials and equipment. The guidelines also address the design, construction, integrity, sterility, validation, monitoring, and control of closed systems to ensure aseptic conditions and minimize the risk of contamination. Join us to explore how our cell bank manufacturing service is striving to establish a closed manufacturing process, detailing the development of our two-phase approach which promises the most reliable process to date to meet Annex 1 expectations.
In this webinar, you will learn:
- What a "traditional" cell bank manufacturing looks like and how it compares to the "Closed System Manufacturing"
- How our custom process and designs integrate to create an all-encompassing closed system production in line with Annex 1 compliance
- How we quantify the number of times we open and close your growth vessels to reduce risk
- Our development runs and results, and what they mean for your manufacture
- About how our integrated electronic laboratory notebooks (ELNs) ensure accuracy throughout the production
Speakers
Angela Waugh
Merck
Global Scientific Lead, Manufacturing Value Stream
Angela has had various roles in her 22 years with Merck, from associate scientist to department manager, and she is currently the Global Scientific Lead for the Manufacturing Value Stream. In this role, she supports the global manufacturing teams, and clients and has a strong focus on regulatory compliance. Angela spent time building clinical trial experiences during which she developed a strong knowledge of GMP requirements. She holds a degree in applied biosciences from Glasgow Caledonian University.
Jorge ‘Steven’ Acuna
Merck
Senior Process Engineer
Jorge ‘Steven’ Acuna is a senior process engineer in our manufacturing group. With more than 6 years of experience in the organization, he has thawed, processed, and filled countless of GMP cell banking productions. Today, he leverages his laboratory experiences to develop safer, and more efficient processes for the group. Steven holds a chemical and biomolecular engineering graduate from the University of Maryland.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
期间:1h
语言:English
场次 1:往期 August 29, 2024
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