ISPE, a global not-for-profit association of 24,000 technical professionals working in the manufacturing and drug development sectors of the pharmaceutical industry, announced today a major extension of its Product Quality Lifecycle Implementation® initiative (PQLI®) further into biotechnology. This significant development comes after the decision of the CMC-Biotech Working Group consortium to provide their A-Mab case study to ISPE. The public availability of the final version of this case study will be announced during the PQLI session entitled, “Regional Regulatory Experiences Implementing the ICH Quality Vision” held on November 10, during the Society’s Annual Meeting in San Diego, California, USA.

“I’m delighted by the decision of the BWG-CMC group,” said ISPE President and CEO Robert P. Best. “This marks a significant opportunity for PQLI. We can now provide even greater support to the biotechnology community in the implementation of the advanced concepts of Quality by Design. We will introduce the case study at our Annual Meeting, and we have plans to use it extensively around the world in discussions with industry and regulators throughout 2010 and beyond.”

The CMC-BWG consortium comprises some 40 members from seven companies (Abbott, Amgen, Genentech, GlaxoSmithKline, Lilly, Medimmune, and Pfizer) and was established in 2008 to develop a case study illustrating how the principles of Quality by Design (QbD) can be applied to the development of biotechnology products, focusing on monoclonal antibodies. The A-Mab case study discusses the development of a monoclonal antibody and incorporates many advanced and aspirational QbD concepts.

“The CMC-BWG team has created an amazing and unique case study that is generating intense interest and excitement amongst the Industry and Regulatory Agencies around the world,” said ISPE PQLI Project Manager, John Berridge, who served as one of the facilitators for A-Mab. “Many have questioned whether the principles of QbD are applicable to biotechnology. A-Mab answers that question with a resounding ‘yes.’ The mission was to describe a future state based on new ways of thinking and A-Mab definitely challenges the sometimes conservative ways industry does things today. We were constantly pushing the envelope to capture an aspirational QbD state showing enhanced product and process understanding. This is not a mock submission seeking regulatory approval. A-Mab provides many illustrative, sometimes controversial, examples of ways to implement QbD and will stimulate discussion about how the science supports these examples and how we can enhance future biotechnology product realization. This is an exciting ‘next step’ in the biotechnology work of PQLI.”