Securing Your Cell Banks: Embracing Closed System Technologies for EU GMP Annex 1 Compliance

WEBINAR

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