Yesterday, consultants Howard Levine, Susan Jones, and Alex Kanarek of BioProcess Technology Consultants posted an item on their BioProcess Blog–titled “The Ongoing Challenges of Applying QbD to Biopharmaceutical Products“–reflecting upon events at the recent BioProcess International confererence in Providence. In particular, the trio discuss OPS Director Helen Winkle’s keynote talk on “regulatory modernization,” and Winkle’s summary of a recent proprietary report conducted by McKinsey & Co. that suggested that FDA needs to get its QbD house in order. Write Levine, Jones, and Kanarek:
What are the must-read articles for would-be practitioners of QbD? I recently posed this question on LinkedIn, and have received several “nominations.” (And we welcome your suggestions.) One seminal article mentioned is “Quality by Design for Biopharmaceuticals,” published last year in Nature Biotechnology and coauthored by FDA’s Helen Winkle and consultant Anurag Rathore, then of Amgen. (Rathore has also coedited, with Rohin Mhatre, a book by the same title, published by Wiley in 2009.)
Anyone looking for hopeful signs of change in the ongoing industry/FDA impasse on smart manufacturing–specifically, PAT and QbD–was bound to be disappointed by this week’s FDA “Partnering with Industry” meeting in Bethesda.
At a panel discussion at Emerson’s Users Exchange in September, Helen Winkle, Director of FDA’s Office of Pharmaceutical Science at the Center for Drug Evaluation and Research, discussed the need for industry, and reviewers, to focus on information that is critical to product quality and safety.