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Mar 1, 2011 (Vol. 31, No. 5)

CMOs Seek "the" Competitive Edge

Established Practices Like Lyophilization and Six Sigma Are Finding Novel Uses in Biotech

  • Productivity

    Xcellerex’ FlexFactory® is a bioprocessing manufacturing platform based upon single-use solutions, designed as modules and optimized cleanroom space. The FlexFactory is designed for a specific need, validated, and operated, and then may be transplanted to a new site without issues with proprietary cell lines, media, and technology that may limit a biotech’s future options. Xcellerex operates its own FlexFactory and also sells FlexFactories to clients.

    “The automation system used to operate our FlexFactory is a purpose-built, application-specific tool for bioprocess operations, covering both development and manufacturing,” Ken Clapp, senior director of global marketing and product management, explains. “The software integrates the typically separate up- and downstream unit operations and associated equipment into one comprehensive automation environment.”

    The result, Clapp says, is a manufacturing facility that can be built and deployed quickly and less expensively than its traditional counterpart. “Integrating automation with disposable manufacturing, with access to contract development and manufacturing services, helps organizations become more productive by aligning manufacturing capacity more closely with regulatory approval,”helping production to start sooner.

  • Comprehensive Services

    Click Image To Enlarge +
    Cook Pharmica’s high-speed syringe line under barrier isolator

    One of the concerns in outsourcing aspects of development and manufacturing is the risk that inefficiencies will creep into the system and that critical knowledge will not be transferred successfully. Brian Arnold, brand and marketing manager at Cook Pharmica says that working with a CMO that provides comprehensive service at a single location minimizes wasted time, redundancy, information loss, and the number of relationships that must be managed.

  • European CMO News

    RecipharmCobra Bio recently received European patents for its Xer-cise technology, which genetically modifies bacteria without leaving antibiotic resistance genes on their chromosomes. As Rocky Cranenburgh, Ph.D., head of molecular biology and inventor of Xer-cise, explained, “The system uses Xer recombinases, which are native to bacteria.”
    The Xer-cise cassette consists of an antibiotic resistance gene flanked by dif sites—the recognition sequence for Xer recombinases—and regions homologous to the chromosomal target locus. That cassette is inserted into the target bacterium by homologous recombination.
    The Xer recombinases resolve the two directly repeated dif sites to a single site, excising the intervening antibiotic resistance gene. “That reduces the steps involved,” Dr. Cranenburgh says, because, “once inserted, you don’t have to transform the bacteria with an additional plasmid carrying a foreign recombinase gene, which subsequently needs to be removed from the cell.”
    “Xer-cise has enabled molecular biologists at RecipharmCobra and elsewhere to rapidly construct bacterial strains that are not antibiotic resistant, and are therefore advantageous for the commercial production and delivery of biologics,”adds Simon Saxby, vp of biologics.

    Richter-Helm BioTec

    Richter-Helm BioTec reported that it has modified its bioreactors to use Pichia pastoris. “That technology is very much in demand now,” because of its ability to secrete products and to manufacture  complex proteins, such as new antibody formats, said Kai Pohlmeyer, Ph.D., head of business development. The firm also implemented advanced technology to process and manufacture plasmid DNA, which increases yield and maintains highest quality, Dr. Pohlmeyer noted.
     Last autumn, Richter-Helm added expanded bed adsorption (EBA) chromatography to its technological mix. “With the implementation of EBA chromatography, clients can bypass initial recovery steps because the molecule of interest selectively binds to the EBA material, even from crude broth. We also optimized our E. coli expression systems and feeding strategies for fermentations, increasing yields of 10–20 g/L,” he continued.
    To further process the increased amounts of raw protein, large-scale  chromatography equipment was added.

    Boehringer Ingelheim

    Boehringer Ingelheim is honing its global strategy, fielding a local team of representatives to be closer to the customer, and making its technologies more widely available to customers through bundling, according to Barbara Esch, Ph.D., marketing communications business intelligence.
    Those technologies include the development of new expression systems. The E. coli genome integration system, for example, expresses recombinant proteins by integrating the gene of interest into the genome instead of placing the corresponding DNA onto an expression vector, Dr. Esch explained. Therefore, when the E. coli cells divide, each genome retains the gene of interest and expresses it at induction.
    “We also have downstream technologies,” continued Dr. Esch, and adapted the crystallization purification step long used in chemistry for applications with stable entities, including interferon and some antibody fragments.

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