Articles | Pharma QbD

Inside PAT at Pfizer: Using Mid-IR to Monitor Reactions

Pfizer’s Ian Clegg and his PAT team at Sandwich Labs in the U.K. have posted a video showing three sequential chemical reactions within the same vessel.

Morgan Stanley to Drug Manufacturers: Get Out of R&D Altogether

The Search & Development model is the only one that makes sense for most manufacturers, says a new report from Morgan Stanley.

Emil at IFPAC: Daily QbD/PAT Notes from Baltimore

Emil Ciurczak shares daily experiences and highlights from the IFPAC annual conference in Baltimore.

Design for Six Sigma: A Potent Supplement to QbD

The tools of Design for Six Sigma help development teams to find the “vital few” and build on the strengths of Quality by Design.

Understanding the Basics of Peptide and Protein Manufacturing

A look at the applications and markets for these fundamentally different large molecules.

Paul McKenzie’s Recipe for Success with QbD

Tying clinical data to CMC will be critical, but it requires a new infrastructure and implementation based on knowledge and information management

Does Six Sigma = QbD in Production?

The Six Sigma methodology is fully aligned with Quality by Design.

Getting Quality Professionals on the Same Page (and Speaking the Same Language)

Dyadem CEO Kevin North discusses the challenges of Quality Risk Management and how software (such as his Stature solution) can get global teams on the same page.

Musings of a QbD Pessimist

Dr. Prabir Basu is a firm believer in the power and potential of Quality by Design, but a skeptic when it comes to its widespread implementation.

Thoughts on Applying QbD to Analytical Methods

QbD has been applied to manufacturing processes but can it be applied to analytical methods?