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 blog post on the 4th PDA Europe Workshop on Monoclonal Antibodies, I touched upon some of the issues discussed around the QbD paradigm, the assessment of critical quality attributes and what this actually means to industry and regulators alike. There was plenty of discussion and debate, with one or two people questioning whether a QbD approach was even practicable. Read more »

Ok, so there wasn’t really a war on at the 4th PDA Europe Workshop on Monoclonal Antibodies, though there was plenty of mildly heated discussion. I simply could not resist the Lucas reference.

Conducted in Basel (Switzerland) in mid-June, the workshop was fully attended, but relatively small, such that it could “foster a feeling of closeness and networking”, according to Richard Levy, senior vice president, scientific and regulatory affairs at the Parenteral Drug Association (PDA). And indeed it did; the numerous coffee breaks were a great opportunity for industry peers and regulators to mix and continue discussions initiated in presentations. Perhaps any bigger, and the sense of relaxed community would be lost… Read more »

Reading PharmTech’s October article on Critical Challenges to Implementing QbD gave me the impression that we might have the road map to Moksha or Nirvana. Unfortunately that was not meant to be. Somehow there is a belief that PAT in pharmaceutical industry is the roadmap to QBD, pharmaceutical industry salvation. In this article, blame of not achieving “pharmaceutical industry salvation” has been attributed to unfamiliarity with the used equipment and corporate culture. I do not believe either of these is completely true. Read more »

“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 Pharmaceutical Technology Conference in Philadelphia, PA. Read more »

We’ve all heard that quality by design and science/risk-based approaches to pharmaceutical manufacturing require a paradigm shift among industry. Well, that message was reinforced again today at the 3rd Annual Pharmaceutical Technology Conference in Philadelphia, PA. Read more »

I’m here at the 3rd Annual Pharmaceutical Technology Conference in Philadelphia, PA. Hot on the agenda is quality. Quality by design, quality via process validation, quality via life cycle production. Nick Cappuccino presented the first session of the morning on ICH Q8, 9, and 10 implementation. Dr. Cappuccino is a member of the ICH Quality Implementation Group. Read more »

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. Read more »

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 Drug, Chemical and Associated Technologies Association (DCAT). ExcipientFest Americas is an exhibition and educational program that addresses technical considerations in excipient selection and formulation development as well as sourcing and supply-chain issues for excipients. Read more »

I participated in an ISPE webinar yesterday with FDA’s Grace McNally regarding the agency’s recently released draft guidance, Process Validation: General Principles and Practices. The guidance is meant to serve as a revision to the 1987 Guideline on General Principles of Process Validation. Read more »