I’m here in Seattle at the USP Science and Standards Symposium, which is focusing on all things biologic and biotech. Representatives from a majority of the pharmacopeia’s expert panels are here, as are a few FDA officials, and industry members from around the world–some 30 countries are represented in fact. Various new approaches by USP are aiming to help industry better understand, develop, test, and manufacture biological products, including biosimilars.
Among the presentations and discussions being had, here a few summary points:
-Fingerprinting, or super characterization, of drugs may or may not work for biotech. Figuring out what fraction of potential attributes of a certain product, and which are meaningful, is more crucial in today’s pharma manufacturing and regulatory environment. Along these lines, critical quality attributes (CQAs) are becoming more and more important as QbD approaches for biologics gain traction. For those interested in real time release testing or getting rid of some end product tests, unfortunately, it won’t be as easy for biologics as it is for the small molecule sector.
-USP’s new horizontal approach to developing standards (see back story) is taking shape. With the goal of developing CQAs for certain product classes, such as mAbs or peptides, the pharmacopeia is in the process of drafting two new mAb chapters focusing on CQAs, tests, and methods. Binding chapter <129> will inclue a list of CQAs for recombinant therapeutic mAbs that can help assure their quality as well as test details to measure these attributes, and ultimately, limits. Informational chapter <1260> will provide more method details and best practices. USP is aiming to make the chapters flexible but setting limits will require a great deal of collaboration and compromise. Expect to see a public draft of each new chapter mid-year 2012.
-Platform technologies for biologic development may be the way to go. Case studies were presented at today’ session, demonstrating how to apply platform processes in early development stages to save time, costs, and build in quality. Challenges with multispecific mAbs and single cell-line development remain with this approach, but nonstatic platforms may provide solutions in the future.
-It’s clear from the vibe at the conference that industry is eager to get moving on biosimilars, as well as innovator biologics, but many questions and challenges remain, especially on the regulatory front. With the Biologic Price Competition and Innovation Act still awaiting implementation and FDA guidance, industry seems hesitant to submit any applications–in fact no applications have been submitted to date for the 351 (k) biosimilar pathway. Some noted that FDA needs to move quickly to answer key questions so that innovation–and more importantly–patient access to drugs–can move forward.
Stay tuned for more details including podcasts with key USP players.
Podcasts are now live:
US Pharmacopeia Leaders Discuss the Future of Biologics and Biosimilars
Senior Managing Editor Angie Drakulich interviews leaders and speakers from the US Pharmacopeia 2011 Science and Standards Symposium on emerging topics in biologics, including biosimilars, new USP monoclonal antibody chapters, FDA approvals, and more. Featuring USP’s Tina Morris and Matthew van Hook, and Engel & Novitt’s Gillian Woollett.