May 2009

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…

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…

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…

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…

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…