Multiproduct facilities are increasingly integral to corporate biologics network and supply chain strategies. Manufacturing capacity strategies ensuring appropriate facility design and procedural controls to manage the risks of producing multiple products are critical to the successful deployment of commercial and clinical supply plans. A Chemistry, Manufacturing, and Controls (CMC) Strategy forum was held in Bethesda, MD, in August 2011 to highlight various challenges, risks, and control strategies associated with multiproduct facilities. Multiproduct strategies for the manufacture of a…
Supply Chain
Establishing Strategic Supplier Partnerships to Facilitate Manufacturing Success
In November 2009, Talecris Biotherapeutics announced an ambitious US$269 million expansion of its Clayton, NC, manufacturing facility. The company was subsequently purchased by Grifols, Inc. in 2011. Constructing a new facility with a state-of-the-art manufacturing process intended to generate clinical products involves top-notch project management, exceptional fortitude, and numerous supply chain decisions. Suppliers are often relied on to provide standard product support. When used effectively, they can be an invaluable resource beyond basic services. Additional support may include…
Participating in the Rx-360 Pilot Joint Audit Program
The Rx-360 consortium has had a profoundly positive impact on pharmaceutical manufacturers and their suppliers. As an international, nonprofit, pharmaceutical supply chain group (established in 2009), its mission is to “create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by enhancing product quality and authenticity throughout the supply chain” (1). The list of consortium members (www.rx-360.org/Membership/ListofMembers/tabid/71/Default.aspx) is diverse and presently includes both pharmaceutical manufacturers and suppliers (24 and…
Carrier Protein Outsourcing
Vaccines represent a significant, increasing area of product development within the biopharmaceutical industry. The segment includes several blockbuster commercial products, nearly 300 vaccines currently in development, and many more candidates in various stages of research and preclinical development (1). The 2010 worldwide vaccine market was ~US$20 billion and is projected to approach $30 billion by 2015 (2). Conjugate vaccines sales currently exceed $7 billion and are expected to increase substantially. Conjugate vaccines (covalently linked polysaccharide and protein) have…
Reducing the Environmental Impact of Single-Use Systems
Committed to sustainability, EMD Millipore is working to provide solutions for the life sciences industry. This commitment is driven by four global issues: climate protection, global health, clean water, and resource efficiency. The company is designing product and process improvements to address these challenges and meet customer expectations. Figure 1: () Life-cycle assessment (LCA) is one of the most rigorous tools we use to help us understand and quantify our products’ environmental impacts (Figure 1). This holistic,…
Sustainabilty Is Good for Business
James Cerruti is senior partner of strategy and research for Brandlogic, a full-service brand consultancy that published in June its 2011 Sustainability Leadership Report: Measuring Perception vs. Reality in partnership with CRD Analytics. The report measured actual and perceived performance of environmental, social, and governance (ESG) factors for 100 major corporations. The report is based on a survey of key audiences who are considered to be “highly attentive” to ESG issues: investment professionals, purchasing and supply chain managers, and graduating…
Recommendations for Cell Banks Used in GXP Assays
Cells and cell-derived reagents form the basis of an operationally challenging class of test methods used in execution of product potency testing (stability and lot release), assessments of pharmacokinetic/ pharmacodynamic (PK/PD) profiles, detection of antidrug antibodies (ADAs) or neutralizing antibodies (NAB), and characterization and comparability testing of biopharmaceutical products. Frequently, cell-based assays provide the only measurement of the tertiary/quaternary structure of each batch of product at the time of lot release and during stability testing to assist in determining product…
Make Innovation Sourcing a Business Strategy
A recent study published by CAPS Research (the research arm of the Institute of Supply Management), underscores the importance of organizations adopting external innovation rather than relying solely on their internal research and development (R&D) efforts. Some companies set goals to increase revenues by adopting external innovation. Procter & Gamble, for instance, wanted to attain 50% of its revenues through external innovations — that is, licensing technologies — over five years (1). A joint project from CAPS Research with Western…
Glass Delamination and Breakage
Although glass is widely considered to be the most traditional and cost-effective option for a parenteral drug container or delivery system, it may not always be the most economical or the best choice for certain products. With knowledge emerging about the suitability of materials in contact with drug products, it is time to look at alternatives that may offer a more appropriate choice and mitigate the risks associated with glass. As single-use technology finds its way into upstream…
Sustainability in Bioprocessing
The concept of sustainability has evolved over the past few decades to describe conditions for harmonious coexistence of industry and nature while meeting socioeconomic requirements of present and future generations. For this environmentally focused report, I like the simple definition offered by Armstrong International, a provider of steam, air, and hot water systems that improve utility performance, lower energy consumption, and reduce environmental emissions. According to a brochure that in part describes its work with Pfizer, Armstrong defines…