Biotechnology Progress

Edited By: Michael M. Domach

Impact Factor: 2.34

ISI Journal Citation Reports © Ranking: 2011: 25/128 (Food Science & Technology); 70/158 (Biotechnology & Applied Microbiology)

Online ISSN: 1520-6033

Associated Title(s): AIChE Journal, Environmental Progress & Sustainable Energy, Process Safety Progress

Virtual Issue on QbD and Chemometrics

Implementation of Quality by Design (QbD) and Process Analytical Technology (PAT) for Biologicals

The concepts of Quality by Design (QbD) and Process Analytical Technology (PAT) have been gradually gaining momentum in the biotech industry since the publication of the FDA’s PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance and the ICH Q8, Q9 and Q10 guidelines. A significant effort has been made both by industry and the regulators in the last decade in partnering and solving issues that the biotech industry faces when implementing these concepts.

Despite this considerable effort, implementation of QbD and PAT in the biotech industry continues to be marred by significant challenges. While companies have started applying these concepts to a limited extent, successful approval of a QbD-PAT “application” is still awaited. The challenges seem to originate from the fact that biotech products and processes are complex. While the industry has evolved over the past decade to understand the effect of process parameters on the various product attributes, our understanding is extremely limited on the effect of the various attributes on the safety and efficacy of the product. Similarly, the effect of some of the complex raw materials that we use is also not well characterized. What everyone needs is case studies that showcase these applications and elucidate how to overcome the challenges that we face during implementation.

Biotechnology Progress has been one of the front runners with respect to publishing case studies that serve this purpose. This virtual issue highlights this fact and presents a few chosen papers that highlight the scope of the journal and the unique platform it offers. Topics that these papers address include identification of critical quality attributes (CQA), impurity characterization, high throughput process development (HTPD), process monitoring, raw material testing, computational fluid dynamics (CFD) and process modeling.

We hope that the readers enjoy this issue and feel encouraged to submit more papers that showcase implementation of QbD and PAT.