Conformia And Leading Biotech Manufacturers To Collaborate In Unprecedented Effort Of Advancing Application Of Quality By Design Paradigm In Biotech Environment
Conformia, the market leader for product/process lifecycle management (PPLM) solutions for the pharmaceutical and biotech industries, recently announced the formation of the Chemistry Manufacturing and Controls (CMC) Biotech Working Group, an expansion of the CMC-IM Working Group formed in July 2007. The group, which includes seven leading biotech industry players, is designed to enable the creation of a fictitious but realistic example of a monoclonal antibody whose development program embraces the ICH quality vision (ICH Q8, Q9, and Q10). The goal of the case study is to provide a series of examples that can be used to assist companies in interpreting the ICH quality guidelines and applying them to real life scenarios.
"The ICH documents provide a science based approach for assuring quality in the manufacture of medicinal products," said Dr. Kenneth B. Seamon, Institute of Biotechnology, University of Cambridge and co-facilitator of the CMC Biotech Working Group. "The CMC Biotech Working Group will provide additional detail on approaches for implementing the harmonized guidance that will be transparent based on the best science. This will provide significant business benefits to the industry as well as facilitate a more innovative and comprehensive approach for national authorities to review and assure the quality of biopharmaceuticals."
"Pfizer is pleased to work with Conformia on this important initiative," said James Spavins, vice president, regulatory CMC/QA at Pfizer, Inc. "We look forward to collaborating with the other companies in the CMC Biotech Working Group to advance discussion and create examples of Quality by Design (QdB) for the Biotech Industry."
This new collaboration, which will include Amgen, Genentech, Abbott, Medlmmune, GlaxoSmithKine, Eli Lilly, and Pfizer, is built on Conformia's experience and leadership conducting the development of a mock case study for large pharmaceuticals (called ACE) and the formation of the CMC-IM Working Group launched in 2007. The CMC Biotech Working Group is an extension of this not-for-profit industry effort to advance understanding of the ICH quality vision across the globe. Conformia has been a CRADA partner of the FDA since 2006 and has successfully launched a workshop series centered on case study discussion. The purpose of Conformia's CRADA is to identify how the core principles of ICH can be applied in pharmaceutical development and to better understand where the pharmaceutical firms face challenges as they bring new drugs to market and attempt to maintain highest levels of quality.
The Conformia CRADA findings from the pilot study indicated a significant unmet need in the availability of examples for biotech product/process development. Furthermore, according to ICH, the top 30 companies, by fully implementing the ICH guidelines, stand to save a total of $8 billion a year. The CMC Biotech Working Group will advance collective understanding to help accelerate adoption of these guidelines for a biotech development and the production environment.
"We can now leverage what we learned previously through creation of the ACE case study, which focused on a small molecule drug development paradigm embracing the ICH quality vision, and build upon that understanding in the biotech arena," said Anjali Kataria, founder of Conformia and principal investigator of the CRADA with the FDA. "The lessons we learned from our CRADA recognized a strong desire for better industry/agency communication as well as a need for collaboration across the board to apply the QdB paradigm to the biotech industry."
Kataria continued by explaining, "The outputs of the CMC Biotech Working Group will not only be available for the industry, but also for regulators across the globe who seek to better understand how the concepts of the ICH quality vision might be applied in day-to-day practice inside firms. This will undoubtedly help bring the level of discussion between regulators and the industry to a deeper understanding of each other."
"The level of commitment from all the companies participating in the CMC Biotech Working Group demonstrates a singular intention to facilitate understanding of the new quality paradigm," said Dr. John Berridge, quality consultant to Conformia and working group co-facilitator. "Together, senior leaders from many top pharmaceutical and biotech companies will debate and share views on the core principles to create a valuable case study of a monoclonal antibody for pharmaceutical development teams to reference as they implement the new ICH guidelines."
The outputs of the CMC Biotech Working Group will be released to the industry in Spring 2009.
About Conformia
Conformia Software provides product/process lifecycle management (PPLM) software solutions to pharma and biotech enabling design, development and transfer. These solutions enable companies in highly regulated industries to save significant time and money through major improvements in product/process development operations. Specifically, Conformia can help companies improve product development cycle times (speed), reduce risks and decrease costs. For more information and to download the ACE Case Study, visit www.conformia.com.
SOURCE: Conformia Software