CMC Forums

The Role of Higher-Order Structure in Defining Biopharmaceutical Quality

    Cosponsored by CASSS (an International Separation Science Society) and the US FDA, the 17th CMC Strategy Forum was designed to explore the relationships between higher-order molecular structure and quality of therapeutic proteins and peptides, vaccines, and blood-derived products. Understanding those relationships is important to defining and controlling the critical quality attributes (CQAs) of biopharmaceutical products. The forum program highlighted the current state of the art for analytical tools used to monitor higher-order structure. Case studies demonstrating the effects…

From The Editor

          From the beginning, BPI has developed creative, collaborative relationships with industry groups and associations as well as our own Informa colleagues at IBC. We have continuing relationships with Interphex, BIO, and ESACT. Through an upcoming supplement on cell therapies, we are enjoying contacts with ISCT, ARM, CTG, and the Phacilitate conference organizers. The list goes on. Such collaborations take many forms. Some people develop webcasts for www.bpiseminars.com. Others describe technical experiences and insights through manuscript…

Extractables and Leachables

    The 13th WCBP CMC Strategy Forum on extractables and leachables was held in Bethesda, MD, in January 2008. The purpose of this forum, cosponsored by CASSS (an international separations society) and the FDA, was to discuss questions related to extractables and leachables in the context of biopharmaceutical manufacturing and find consensus on some of those topics. Morning sessions began with “Extractables and Leachables: Challenges and Strategies in Biopharmaceutical Development” with program cochairs Stacey Ma of Genentech, Inc., Ingrid…

Measuring Manufacturing Cost and Its Impact on Organizations

    The first article in this periodic series reviewed the impact of cost pressures on the biopharmaceutical industry, in particular the challenges the industry faces in relation to high capital costs, complex processes, and long product development cycles (1). Here we examine what companies are doing to assess costs in decisions about process and technology choices relating to manufacturing of biologic drug substances. We will look into what companies are currently doing and what they need to be doing…

Using Innovation to Drive Competitive Advantage

    Figure 1: () STOCKXPERT (WWW.STOCKXPERT.COM) After spending decades as the “sleepy” segment of the biopharmaceutical industry, vaccines are now seen as one of its highest growth segments. Major pharmaceutical companies — Novartis AG (www.novartis.com) and Pfizer, Inc. (www.pfizer.com), for example — are aggressively entering this area. Those already in it are expanding capacity and increasing business development activity. Indeed, access to the vaccines business was a major driver of Pfizer’s acquisition of Wyeth Pharmaceuticals (www.wyeth.com) (1). Several factors…

Defending the Supply Chain

Competition, whether commercial or military, focuses on two common objectives: making choices and converting those choices into direct action. Like commercial competition, most wars are won or lost through effective or faulty logistics. The Art of War by Sun Tzu is not merely a book about war. Captains do not carry it into battle with them. It is a book about strategy that generals and statesmen study. Mobilizing for war, committing an army to battle, and risking a power base…

Demonstrating Comparability for Well-Characterized Biotechnology Products

Challenges and approaches in demonstrating comparability of a well-characterized biotechnology product after manufacturing changes can be as varied and complex as the products themselves. Participants at the January 2005 CMC Strategy Forum sought to discuss and agree on common implementation strategies for different manufacturing change scenarios. Development of flexible, comprehensive approaches in strategy development addressed evaluation of critical product characteristics, appropriate process steps to test, numbers of lots and levels of testing required, and assessment of product comparability (e.g., trending…