2011

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…

Combination Products for Biotherapeutics

    Combination products (see the “Definition” box) are experiencing steady growth in the pharmaceutical industry. According to one report, about 30% of products currently in development are combination products (1). Expanding interest in such products can be attributed to manufacturers’ need to generate new market value for current products that will soon lose patent, requirements for long-term patient care, pressure to reduce healthcare costs, and consumer interest in localized drug delivery with improved therapeutic effectiveness (2). During the 2008…

From The Editor

          Welcome to 2011 — and our ninth year of publication. This milestone is both rewarding and a bit daunting. We want to drive discussions rather than just reveal their results. Venturing into new territories can require more than a simple roadmap. Think of bioengineers as experienced “cooks” who have reached a confidence level allowing them to combine recipes and create new “menus” from existing processes. Same ingredients, different combinations — with tasty new chemistries. But…

US Supreme Court Ruling Provides Clarity for Life-Science Companies Facing Litigation

    When a company is involved in litigation, the court in which its case is heard can have a significant impact on the proceedings. For life-science corporations, this is especially true. Because their products are often distributed to consumers across the United States and the world, such companies can benefit from the consistency and efficiency provided by federal courts. Federal courts provide uniform procedures across the United States, have mechanisms for consolidating similar claims across state lines, and are…

Review, Approval, and Marketing of Biosimilars in the United States

    Development, testing, review, approval, and marketing of biosimilar drugs in the United States presents unique safety and regulatory challenges (1). By contrast with traditional small-molecule drugs, biologics derive from sources such as genetically engineered cell lines, plasma, and tissue specimens (2,3). Patents on first-generation biologics approved and marketed in the United States have begun to expire, thereby opening the market to less-expensive “generic” versions. The complexity of biologic drugs and the specificity of their source materials, however, make…

Stability Considerations for Biopharmaceuticals: Overview of Protein and Peptide Degradation Pathways

To ensure product safety and efficacy, protein therapeutics must meet defined quality characteristics immediately after manufacture as well at the end of their designated shelf lives. Many physical and chemical factors can affect the quality and stability of biopharmaceutical products, particularly after long-term storage in a container–closure system likely to be subject to variations in temperature, light, and agitation with shipping and handling. Compared with traditional chemical pharmaceuticals, proteins are considerably larger molecular entities with inherent physiochemical complexities, from their…

Improving Process Economy with Expanded-Bed Adsorption Technology

    Most biopharmaceutical processes involve purifying proteins and peptides from various sources. Typically, purification schemes contain multiple unit operations, including several chromatographic steps to ensure safe removal of critical impurities and contaminants. Each step affects the overall process economy by increasing operational cost and process time and by causing product losses. Carefully designing a purification procedure to reduce the number of steps is an efficient way to reach high process economy. Expanded-bed adsorption (EBA) technology is a powerful alternative…

Single-Use Tangential Flow Filtration in Bioprocessing

    Single-use (SU) components are widely accepted in bioprocessing due in part to improvements in component design, a wider range of products, and increased scalability. Benefits driving their increased use include elimination of cleaning, improved system flexibility, and reduced risk of contamination. Nonetheless, companies now question how far disposables can be incorporated into bioprocessing unit operations. Results of the second annual survey of the bioprocessing market fo single-use solutions showed that >90% of respondents considered filtration well suited for…

A Biomass Monitor for Disposable Bioreactors

    Of the available on-line biomass assay types, radio-frequency impedance spectroscopy (RFI, often referred to as capacitance) is generally regarded as the most robust and reliable method for monitoring viable biomass during fermentation and cell culture. The first article to show that capacitance could be used to estimate microbial biomass dates back over 20 years (1). Today the technology is routinely used for monitoring and controlling mammalian cell culture processes and high-density yeast and bacterial fermentations in research, process…

Global Marketplace

  Laboratory Automation         Product: Octet platform Applications: Label-free molecular binding analysis Features: ForteBio chose Hudson Robotics to provide automation capability for its Octet biolayer interferometry analytical instruments. The platform includes Dip and Read biosensors, reagents, and assay kits for analyzing biomolecular interactions in 96-and 384-well microplates. The two companies developed out-of-the-box, integrated automation for Octet QK384 and RED384 systems with Hudson’s PlateCrane EX robotic arm and Micro10x robotic reagent dispenser. A bar-code scanner reads and records…