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Jul 1, 2010 (Vol. 30, No. 13)

Resistant Bugs Necessitate Tougher Tactics

A Handful of Companies Report Progress in Developing Next-Generation Antibacterial Agents

  • Sidebar: Notes from the Floor at BIO 2010

    > Abbott continues to expand its biologics manufacturing capabilities for commercial manufacturing and clinical supply of drug substances, according to Ralph Lambalot, plant manager, biologics production, Abbott Bioresearch Center. Recent capacity expansions at its Barceloneta, Puerto Rico facility include an additional 12,000 L bioreactor for commercial supply of Humira, as well as the introduction of small-volume parenteral filling capabilities. The addition brings to the Puerto Rico facility the potential to readily expand to two trains with a combined 60,000 L capacity in the future.

    In October, Abbott will bring its first fully disposable manufacturing suite online with the introduction of a 500 L cGMP manufacturing train using all single-use systems at its Worcester, MA facility. The disposable suite will enable Abbott to further accelerate clinical-development timelines with rapid changeovers for new product introductions, added Michelle Calhoun, commercial operations, marketing. The addition provides a fifth cGMP manufacturing train to the multiproduct facility’s existing four trains equipped with 3,000 L and 6,000 L bioreactors.

    > Jim Hamby, Ph.D., vp of business development at Ash Stevens, reported that the company is in the early phases of a multiyear expansion that will add new capacities and capabilities to the company’s manufacturing plant in Riverview, MI. Upgrades will include new process-development laboratories, a high-potency drug development and manufacturing containment suite, a state-of-the-art materials-handling and storage facility, and a large-capacity reactor suite, among other enhancements.

    “Our expansion is fueled in part by an emerging trend toward more innovator small molecule drug development and manufacturing staying onshore,” said Dr. Hamby.

    > Lumigen, a Beckman Coulter company, recently introduced its HyPerBlu chemiluminescent substrate that detects hydrogen peroxide. According to the company, the substrate, which is a one-component solution with enhanced sensitivity and stability, is useful for research purposes and is amenable to high-throughput screening (HTS).

    The company also has a new Sparcl™ technology that is a peroxidase-induced chemiluminescent immunoassay system to detect close proximity of antibodies and their analytes. Sparcl is designed for research purposes and it too is appropriate for HTS. According to Anthony Gaglio, product manager, strategic marketing, Lumigen is developing its own instrumental detection system for this flash chemistry-based assay, which is expected to be launched next January.

    > Genetic Analysis works on molecular diagnostics and, in particular, creating “gut profiles” of bacterial flora. Applications for its technology include not only developing new drugs but also assessing the effect of drugs on the gut. Morten Isaksen, Ph.D., CEO, suggested that bacterial molecular diagnostics is a part of the growing trend for personalized medicine.

    The company’s initial offering is GA-map™, an array technology that profiles a patient’s gut microbiota, providing screening of 100+ samples/day. The company currently is finalizing tests for infants and expects to move into adult screening tests later this year. Another application is to use these tests for research purposes to compare normal and diseases profiles. The company is looking for collaborators in these areas.

    > iSentio also specializes in molecular diagnostics, but for mixed bacterial sequencing from clinical specimens. According to May Kristin Roen, CFO, the company’s new software tool, RipSeq®, has the ability to detect and identify bacteria directly from clinical samples by broad-range PCR targeting the 16S rRNA gene and DNA sequencing (direct 16S rDNA sequencing).

    With this approach, an answer can be obtained in as little as 5–8 hours in contrast to traditional culturing approaches that take 2–7 days, she pointed out, adding that advanced algorithms eliminate the need for culture and manual separation of the bacteria prior to sequencing. Roen said this makes direct sequencing relevant for a broader range of clinical specimens including those from abscesses and pleural fluids.

    The company is focusing on increasing the number of bacterial strains identifiable by sequence analysis. Several laboratories are currently using or testing the software application, and iSentio already has customers in seven countries including the U.S. and Germany, continued Roen. The company expects to open the first office in Asia in 2011.

    > PCI Biotech has targeted the development of a novel photochemical drug-delivery technology for use in cancer therapy and various diseases. When illuminated, the introduced photochemical enhances the local effect of drugs because it releases biologically active drugs that are trapped in endosomes. The firm started clinical trials in August 2009 and has so far seen complete regression of all treated tumors, reported Per Walday, CEO. The company is focusing on cancer therapies for the head and neck.

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