Claus Exenberger

Apr 12, 2024 | bioprocessonline.com | Nathan Parker |Claus Exenberger |Jean-Sebastien Steffen |Ian Burdick

The introduction of ICH Q14 to analytical procedure development provides guidance on the recommended approach to assay development and the justifications regulatory bodies require to demonstrate the development of a method. While applying an AQbD approach may require more upfront work, the advantages are a better understood and more robust method, with greater regulatory flexibility.

Mar 7, 2024 | bioprocessonline.com | Claus Exenberger

Article | March 7, 2024 By Claus Exenberger, Product Line Management Handling monoclonal antibodies (mAbs) in production is a sensitive process that requires strict safety measures to prevent contamination, product loss and exposure to cytotoxic agents or radioisotopes, which can cause severe health issues. One effective safety measure is the use of closed-system-drug-transfer-devices (CSTDs) to prevent drug substances from being exposed to the environment.