As gene therapies continue to advance, the demand for scalable, reproducible, and efficient potency assays is rapidly increasing—especially for adeno-associated virus (AAV) vectors. Accurate ...

Bioassays are critical for determining drug substance and drug product potency, which is why it is important to understand the fundamentals of developing an effective bioassay. A bioassay measures ...

Three hypothetical analytical target profiles (ATPs) are provided, reflecting the current thinking of the the European Federation of Pharmaceutical Industries and Associations Analytical Lifecycle ...

Parallel line analysis (PLA) is often used to analyze biological assays in laboratories that follow GMP (good manufacturing practice) and GLP (good laboratory practice) regulations. This method is ...