QbD in Biotechnology

QbD, or Quality by Design, in biotechnology is a systematic approach to developing and manufacturing products by understanding the process and controlling variables to ensure consistent quality. It involves designing processes with built-in quality, using thorough knowledge of materials, methods, and potential risks. This proactive method helps prevent problems, improves efficiency, and ensures the final product is safe and effective. Essentially, QbD emphasizes planning, understanding, and control from the start, leading to higher quality biotechnological medicines and products.