QbD in Theory and Practice
The pharmaceutical industry has sometimes been slow to embrace ideas that promise great practical benefits. The industry’s ingrained aversion to risk is partly to blame, but it’s usually not the whole story. Take the quality-by-design (QbD) initiative, which posits that the better a company understands a product’s quality attributes, the more likely that product will be safe and efficacious. The industry has generally supported this initiative, and Pfizer has brought it into the spotlight. Read more »
In my first
“If QbD is the ocean of knowledge, then generics are just pulling out of the driveway. We haven’t even seen the beach yet,” said Aloka Srinivasan, PhD, a team leader at the FDA Office of Generics (OGD) and a speaker at today’s keynote session of the 3rd Annual
Innovation, innovation, innovation .. and a call to focus on science and quality-by-design (QbD) principles. Such was much of the talk yesterday at this year’s AAPS National Biotechnology Conference in Seattle. Speakers discussed the tools the biotechnology industry will need for future innovation and how the industry must center on QbD principles, using lessons learned from small-molecule development and even nonregulated industries.
Relationship building and the benefit of deepening collaborative business models between excipient manufacturers and pharmaceutical companies in support of formulation development and manufacturing in a quality-by-design (QbD) paradigm and enhancing supply-chain practices was a key takeaway from ExcipientFest Americas, which was held in San Juan, Puerto Rico, this week. ExcipientFest Americas is operated by the