Industry Leaders Discuss “Quality by Design” at Chapter’s Regulatory Symposium
- Posted by mbraatz
- On February 2, 2017
Industry leaders Bert Frohlich, Director of Strategy and Technology Lifecycle, Shire, and Amy Lachapelle, Lead Consultant & Founder, QbD Strategies, presented “Quality by Design” as part of the Chapter’s recent Regulatory Symposium held at Northeastern University. Well known in the regulatory field with a combined 38+ years of experience in biopharmaceutical manufacturing, the speakers presented a historical overview and an industry perspective on QbD, as well as a practitioner’s take on how to achieve the most benefit for the least effort and implement QbD quickly. See below for links to the slide presentations and speaker bios.
Bert Frohlich opened the program with “The Unfinished Story of QbD in the Pharmaceutical Industry,” tracing the history of Quality by Design from its introduction to its current status. While the initial promise of greater regulatory flexibility through QbD-based submissions has not yet been realized, industry generally accepts QbD and risk-management methodologies as a systematic approach to control strategy construction. Arguably, a comprehensive process and analytical control strategy for a pharmaceutical product is the more important outcome of QbD and the first step towards greater self-regulation. Bert also shared his thoughts on the future direction of QbD and opportunities for alignment and collaboration among manufacturers, suppliers and regulators.
Amy Lachapelle followed with “A Simple & Pragmatic Approach to Implementing QbD” during which she explained that the tools used in QbD provide a framework for transforming R&D data into a “useable asset.” However, the terminology and basic statistical concepts of QbD do not always align with R&D teams. The International Conference on Harmonisation (ICH) guidelines refer to patient-centric focus, risk management, and process control, terminology which may not appear relevant to R&D. Thus QbD is often implemented during the drug development phase. Amy designed her presentation to explain research goals in a manner that aligns with ICH guidelines; and to provide an understanding of the benefits of implementing basic statistical practices early in product development when the costs are the lowest.
For more detail, click on the links below:
The Unfinished Story of QbD in the Pharmaceutical Industry: https://www.ispeboston.org/files/unfinished_story_qb_-frohlich.pdf
A Simple & Pragmatic Approach to Implementing QbD Industry: https://www.ispeboston.org/files/implementing_qbd_-_lachapelle.pdf
Speaker Bios
[sta_anchor id=”Bert Frohlich”]Bert Frohlich, Director of Strategy and Technology Lifecycle, Shire
Bert is a Ph.D. Biochemical Engineer with 25+ years of experience in the biotechnology, pharmaceutical, and chemical industries. He is currently Director of Technology Management at Shire Pharmaceuticals within the Process Development and Technical Services organization but has held positions at Roche, Genzyme, EMD, Amgen and Acambis (now Sanofi) in process/facility design and bioprocess development. Starting from the publication of summary article on Quality-by-Design (QbD: Still in Design? A Report from PDA’s QbD Workshop. PDA Letter, Vol. XLIII – Issue #9 (October 2007)], Bert has maintained an interest in QbD, speaking on the subject at several conferences and leading the design of the QbD business processes at Shire.
[sta_anchor id=”Amy Lachapelle”]Amy Lachapelle, Lead Consultant & Founder, QbD Strategies, LLC
Amy is currently the Lead Consultant at QBD Strategies LLC where she teaches and assists companies with approaches to implementing quality by design. She has 16+ years’ experience with biological research and development, working on purification, development, and characterization of viral vectors for gene therapy at Genzyme then later creating a product stream of protein characterization services for GlycoSolutions. Amy’s knowledge of biochemistry, mathematics, and cGMP requirements led to her belief that implementation of QbD can benefit the biopharmaceutical industry. She has spoken on the topic at the R&D 100 conference (“The Hurdles and Benefits of Designing Quality into Your Drug Product in Early Stage Development”, November 2015) as well as two publications on the subject in BioProcess Online.
