January 2011

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…

IBC’s 26th International Antibody Development and Production Part of IBC’s Biopharmaceutical Development and Production Week

IBC’s Antibody Development and Production conference offers the latest technical and scientific advances in bioprocessing to help companies of all sizes improve speed, quality, and cost in developing and producing antibodies. Exclusive case studies deliver the latest data together with strategic discussion forums that allow the industry’s leading scientists, engineers, and executives to collaborate and find solutions to their most pressing challenges. Gain from companies sharing “lessons learned” from their own experiences developing and optimizing processes and production of antibody-based…

Ongoing Challenges of Applying QbD to Biopharmaceutical Products

Quality by design (QbD) was a hot topic at IBC’s BioProcess International Conference and Exhibition, 20–24 September 2010 (Providence, RI). For her keynote address, Helen Winkle (director of the FDA’s Office of Pharmaceutical Science) discussed the agency’s continuing efforts to improve product quality regulation as well as opportunities and challenges of implementing QbD for biotechnology products (1). Since introducing its 21st Century Initiative in 2002, the FDA has made some headway toward enhancing product quality through QbD (2). The QbD…

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…