May 2009

European Society for Animal Cell Technology 2009 Conference in Dublin, Ireland

    It is a great pleasure for me to express an invitation and welcome message to you for the 21st ESACT Conference in Dublin, Ireland, here in the pages of BioProcess International, one of the most prestigious journals of its kind, “covering the whole development process for the global biotechnology industry.” Ireland is famous for her warmth of heart and poetic spirit, sometimes even brought into conjunction with Irish spirits — uisce beatha, “the water of life” — which…

FDA 21 CFR Part 11 Revisited

Six years after the US FDA applied a narrower scope to its interpretation of 21 CFR Part 11 on electronic records and signatures (1), the agency is ready to release the revised Part 11. The 2008 release of a draft revision of Annex 11 — Europe’s version of Part 11 (2) — put pressure on the FDA to complete its long-overdue Part 11 revision. As I made clear to members of my SmarterCompliance executive advisory group in May of last…

Q&A with Dr. Florian Wurm

In early April, I chatted with the chair of ESACT, Florian Wurm, a professor of biotechnology in the faculty of life sciences of école Polytechnique Fédérale de Lausanne in Switzerland. As chairman of ESACT, what are your duties? How is the chairperson selected, and how long does he or she serve? How long have you been chair? The ESACT chair is elected from among the members of the executive committee, which are elected by the membership. The executive committee organizes…

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…

Stem Cells and Tissue Engineering

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,…

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…

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…

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…

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…