Stem cells are probably the most-discussed — and least understood — potential therapeutics biotechnology offers. Headlines in mainstream media tout their potential benefits and decry their ethical complications. Time magazine featured stem cells on its cover one week in February (1), and an ABC network drama depicted criminals selling stolen cord blood stem cells to the rich and vain as a high-end cosmetic treatment (2). It’s a safe bet that most nonscientists don’t know the difference between embryonic stem cells,…
Friday, May 1, 2009 Daily Archives
Sailing Through Pharmaceutical Risk Management
A Few Small Steps for Biotech Will Yield Giant Leaps for Humankind
Biotechnology’s mission has never been more critical. In a call to action reminiscent of President Kennedy’s challenge to place a man on the moon in the 1960s, President Obama has challenged the scientific community to seek “a cure for cancer in our time.” The challenge is tremendous, but the place to look for such a momentous and meaningful achievement is among the great minds of scientists and inside the research laboratories of biotech companies. And that is but the tip…
IBC’s Sixth AnnualSingle-Use Applications for Biopharmaceutical Manufacturing
IBC’s Single-Use Applications for Biopharmaceutical Manufacturing conference is well known in the industry as the largest, most well-respected event focused solely on disposables. This year’s program provides a thorough education on topics such as equipment technologies, and processes through validation; integrating disposables into facilities; implementation tools; and new data from vendors on how plastics are manufactured. Our faculty of experts will present their most up-to-date knowledge and proven strategies you can implement at your company to ensure it is maximizing…
Global Marketplace
Depth-Filtration Platform Product: Stax disposable depth filter platform Application: Downstream processing Features: Simplicity, intuitive operation, safety, and speed improve the efficiency of depth filtration processes. A stack of single-use depth filter capsules are configured in an ergonomic, vertical design to enable a single operator to load, operate, and unload within a reduced footprint. Single-use capsules eliminate the need for cleaning and associated validation. Interlocking modules are interchangeable and scalable. Contact Pall Life Sciences stax@pall.com Clean-in-Place (CIP) Product: RotaCIP cleaning equipment…
Novel Vaccines and Virology
Vaccines have been around a long time — longer than any other biologic medical products. Since the 1700s, when a British doctor inoculated people against smallpox using Variolae vaccinae (cowpox virus), we’ve referred to such immunizing treatments as “vaccines.” Most children in developed countries grow up knowing there will be occasional “vaccinations,” usually injections, required to get into school and stay there (which may or may not seem like a great thing, depending on who you talk to). Similarly, people…
Increasing MAb Capture Productivity
Continually increasing bioreactor titers is placing pressure on downstream processing, especially chromatography steps, to process the greater mass of protein produced. Whereas an order of magnitude increase has been seen in titers over the last few years, no similar increase has yet been achieved in the capacity of chromatography resins. Meanwhile, the industry is coming under rising pressure to reduce manufacturing costs and the resulting cost per gram of monoclonal antibodies (MAbs) produced. Because of the specificity it offers, protein…
Implementation of Single-Use Technology in Biopharmaceutical Manufacturing
Single-use filtration systems are increasingly replacing traditional stainless steel filter assemblies, piping, and tanks for purification and storage of bioprocess fluids in biopharmaceutical manufacturing. Unfamiliarity with polymeric materials and the need to ensure patient safety, however, have made extractables and leachables from these new components and systems a primary concern of process developers along with specialists in quality, validation, regulatory affairs, as well as agency reviewers. A general risk-based approach to determination of extractables and leachables from disposable bioprocess equipment…
Production of Recombinant Whole-Cell Vaccines with Disposable Manufacturing Systems
Live whole-cell bacterial products have been used as vaccines for many years, and there are currently three such products licensed on the market. Over recent years, however, interest has renewed in this type of product as a delivery system for novel recombinant therapies and vaccines. A number of different organisms have been proposed, such as Escherichia coli and Salmonella species, which might have applicability for such applications. Vaccine applications tend to relate to the potential for low-cost orally delivered products…
Development of a High-Capacity MAb Capture Step Based on Cation-Exchange Chromatography
Protein A affinity chromatography is traditionally used as the capture step for monoclonal antibodies (MAbs) (1,2,3). It yields high purity because only the fragment-crystallizable (Fc) region of an antibody (IgG1 or IgG2) or Fc-containing fusion protein can bind to the protein A ligand. The resulting specificity provides substantial reduction in impurities such as host cell proteins (HCPs) and DNA (4,5,6,7,8). The dynamic binding capacity of protein A chromatography resins is generally ≤40 g/L and depends highly on residence time because…