Ongoing requirements for additional insight and CGMP-compliant measurement have led to interest in new technologies that can be applied to the analysis of many different types of particle-containing fluids. Micro-Flow imaging (MFI) is a robust, versatile, and intelligent vision technology that is increasingly used for evaluating populations of microparticles encountered during bioformulation development (1). It is also being accepted in fill–finish processes and many other biotechnology applications. Features of MFI technology that have contributed to its rising popularity include the…
2009
BioProcess International Conference and Exhibition
IBC’s BioProcess International Conference and Exhibition (BPI) will head back to the US east coast for 2009 to Raleigh, NC. This has become the largest, most respected forum focusing on technical, regulatory, and strategic planning challenges in the manufacture of biotherapeutics. Four comprehensive conference tracks as well as intimate workshops, strategic discussion groups, training seminars, and colocated conferences will continue to provide you with an interactive and lively format all in one location. BPI allows you to meet face-to-face with…
Global Marketplace
Custom DNA Product: McBox luc minicircle and plasmid DNA Applications: Transfection optimization Features: The McBox luc kit includes 100 µg each of certified minicircle and plasmid DNA, both including the firefly luciferase reporter gene. A vial with endotoxin-free water for injection ensures high quality after dilution. Scientists can now directly compare minicircle DNA with a corresponding “classical” plasmid in individual applications. Minicircle DNA contains almost exclusively the gene of interest and its regulating sequence motifs. This provides a safe and…
New Validation Guidance Causes a Stir
In November 2008 the US FDA finally issued a new draft guidance on process validation (1). The original guidance on this topic was published in May 1987, and the FDA explained that “since then, we have obtained additional experience through our regulatory oversight that allows us to update our recommendations to industry on this topic.” The new guidance is intended to reflect some goals of the FDA’s Pharmaceutical GMPs for the 21st Century, an initiative that was finalized in 2004.…
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…