All pharmaceutical products—whether small molecules, monoclonal antibodies, or more complex genetic medicines—must adhere to stringent quality control criteria. Essential to quality control is the identification of critical quality attributes (CQAs), which are defined as the physical, chemical, biological, or microbiological properties or characteristics that should be within an appropriate limit, range, or distribution to ensure the desired product quality.

We sat down with Dr. Srujan Gandham, Associate Director of Analytical Development at Area Therapeutics, to get his insight into the world of CQAs. Here he covers areas around:

• CQAs role in biotherapeutic development
• Analytical tools available for evaluation
• Evolution of CQAs in advanced and novel therapeutics
• CQAs regulatory environment
• Future pharmaceutical landscape

For research use only. Not for use in diagnostic procedures.