February 2011

Understanding Virus Preparations Using Nanoscale Particle Characterization

As regulators become increasingly stringent in demanding a fuller understanding of whole virus preparations, researchers and manufacturers are looking beyond well-known characterization methodologies. Existing technologies for quantifying and characterizing viral preparations such as infectivity assays, quantitative polymerase chain reaction (qPCR), and protein assays provide crucial information but tell only half the story. We evaluated a unique technology developed by NanoSight Ltd. (www.nanosight.com) for visualizing viruses in liquid suspensions, measuring their approximate concentration, and characterizing their state of aggregation. Information generated…

Modeling Perfusion Processes in Biopharmaceutical Production

    Perfusion processes are considered more difficult to model than batch-based fermentation processes because up to a third of a perfusion-based campaign is spent outside “steady-state” production mode. Variabilities in cell density, titer, and harvest rate (HR) during ramp-up necessitate planning and explicit modeling of variabilities in these processes and their subsequent downstream operations. Longer continuous fermentation times require more rigorous attention to risk than do batch-based systems. A flexible purification platform must respond to changing fermentation conditions. Here…

Industrial-Scale Biochromatography Columns Address Challenging Purification Needs

    Chromatographic purification remains the most critical step in biopharmaceutical downstream processing. Its purpose is to separate biologic impurities such as host-cell proteins (HCPs), nucleic acids, and oligomers from a target biologic, which must be purified to very high levels (often >99%). Biological separations usually require medium to high salt concentrations and bear inherent risks of microbial contamination in waterbased process streams. Thus they require specifically designed equipment. Depending on process constraints, chromatographic media, and equipment limitations, biochromatographic separations…

Global Marketplace

Tubing/Hose Clamps Product: Overmolded Tri-Clamp ends Applications: Sanitary fluid management, single-use processing Features: AdvantaPure Overmolded Tri-Clamp ends for PVC, TPE, and TPR tubing and hoses are injection molded from USP Class VI Hytrel material or polypropylene in Tri-Clamp and Mini Tri-Clamp styles. A smooth transition from tubing to clamp reduces bacteria entrapment potential for cleaner connections. The clamp materials are mated thermally (no leachable adhesives) to PVC, TPR, or TPE hoses and certified free of animal-derived ingredients. Miniature through1.5-in. Tri-Clamp…

TIDES Oligonucleotide and Peptide Research, Technology, and Product Development

TIDES is the only event that covers CMC manufacturing of peptide and oligo therapeutics in depth. It offers the largest showcase of providers of services and technology critical to the field and a proven track record of attendance that guarantees a superior networking opportunity. TIDES 2011 has four main content streams: Oligonucleotide and Peptide Manufacturing Technology and Product Development; Oligonucleotide Therapeutics Discovery; Peptide Discovery and Development; and Nucleic Acids Technologies for Molecular Diagnostics. Learn how to solve your CMC manufacturing,…

Working Together to Keep Drugs Safe

    The growing and dangerous counterfeit drug problem is a troubling, global epidemic that can — and does — harm patients who are merely trying to get well. Efforts to address the problem are hamstrung for a variety of reasons: Americans don’t see the immediate threat, this global public health problem needs a coordinated global response, and too many stakeholders are more focused on self-interest than on working together to find a solution. The Partnership for Safe Medicines (PSM)…

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…

Questions to Consider When Thinking About Companion Tests

Personalized medicine is a catch phrase of the 21st century — and with good reason. Advances in genetics and biochemistry promise to tease apart factors that explain why some patients benefit dramatically from a therapy whereas others receive no benefit at all. They also help explain side-effect profiles. To accomplish such lofty goals, drug makers are increasingly partnering with diagnostics companies to develop companion biomarkers. But these companies operate in very different business and regulatory environments, so partnerships can be…

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…