The evolving landscape of quality by design in biologics manufacturing

The rise of biological therapies including vaccines, growth factors, monoclonal antibodies, and recombinant proteins, has revolutionized modern medicine, offering hope for patients with diseases once considered untreatable. However, what makes them so effective also contributes to their complexity, presenting challenges in safety, efficacy, and consistency.

In this article, we explore, alongside Dr. Mansoor Amiji, how the implementation of Quality by Design (QbD) principles has become essential in meeting these challenges and how QbD helps define and control the critical quality attributes (CQAs) vital for next-generation biologics.

Covering areas in:

• Quality by design in biologics development
• Defining critical quality attributes
• Quality in biosimilar development
• The future of biologics manufacturing

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