Anna Lau

Company: National Institute of Health Science

Job title: Chief, Sterility Testing Service

Seminars:

Panel Discussion: Breaking Bottlenecks in Sterility & Safety Testing for Faster, More Reliable Cell Therapy Release 8:30 am

Identify key release challenges, from lengthy sterility timelines to product-specific test compatibility, that delay patient access Compare rapid sterility and mycoplasma testing technologies, what is working, what is not, and how to validate them for your product Review regulatory hurdles and best practices for convincing authorities to accept novel test methodsRead more

day: Conference Day 2 Morning

Interpreting the New US Pharmacopoeia Guidance for Sterility & Microbial Testing in Cell Therapy 9:30 am

Understand the new USP <72> (respiration methods) and <73> (ATP Bioluminescence) chapter requirements for sterility testing of short-life products, official August 1, 2025 Gain insight into the revised USP <1071> (rapid microbial tests for release of sterile short-life products) and timeline for the USP <77> chapter (mycoplasma release testing via molecular methods)Read more

day: Conference Day 2 Morning