Advancing Quality Control Testing in Therapeutic Biologics
Quality control (QC) testing is paramount in ensuring the efficacy and safety of therapeutic biologics. These complex molecules, derived from living organisms, require stringent testing to meet regulatory standards and ensure patient safety. While state-of-the-art molecular methods have been established, many laboratories still rely heavily on animal testing, using protocols developed in the 1970s.
However, in November 2023, the International Council for Harmonisation (ICH) announced the adoption of its Q5A(R2) guideline on viral safety evaluation of biotechnology products and a guideline on validating analytical procedures. These guidelines encourage the biopharmaceutical industry to adopt new standards in biologics QC, including next-generation sequencing (NGS)-based assays.
