Points to Consider When Defining a Microbial Control Strategy for Individualized ATMPs

Points to consider when defining a microbial control strategy for individualized ATMPs

• How are individualized ATMPs different from traditional drugs and off-the-shelf ATMPs?

• Regulatory background

• Microbiological testing: be thoughtful and keep it simple

• The importance of raw material control

• ATMPs: A mindset challenge for Microbiologists

Presented by Friedrich von Wintzingerode, PhD, QC Lead iNeST Project at Roche

Friedrich is QC Lead of the iNeST (individualized Neoantigen Specific Therapy) program at Roche-Genentech.

Friedrich joined Roche-Genentech after earning his PhD in Microbiology and has over 20 years of experience in Quality Control and Quality Assurance in the biopharmaceutical industry, working on various topics including microbiological testing, material specifications, environmental monitoring, cleaning analytics, and analytics for release.

Friedrich has led several global technical teams (e.g. microbial identification, microbiological testing, endotoxin testing, and Low Endotoxin Recovery/LER) at Roche-Genentech. He co-chaired the PDA Low Endotoxin Recovery Task Force, which authored PDA Technical Report No 82 on LER. He is also vice chair of the PDA ATMP advisory board.