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June 15, Vol. 29, No. 12

  • Feature Articles

    • Improving Biomarker Validation
    • Gail Dutton
    • The quest for highly predictive biomarkers is as enthralling as the medieval quest for the Holy Grail and, potentially, more rewarding for patients throughout the globe The current challenge isn’t to identify potential biomarkers, but to validate them, ascertaining that ... more »
    • Tech Transfer Key to CMO Cost Reductions
    • Susan Aldridge, Ph.D.
    • There were several lessons for CMOs at the recent “BioProcess International Conference,” among them notification from Miriam Monge, vp of marketing and disposables implementation at Biopharm Services, that CMOs must significantly reduce development and manufacturing costs... more »
    • Nature and Nurture Benefit Cell Lines
    • Angelo DePalma, Ph.D.
    • Optimizing mammalian cell culture for volumetric productivity involves working on different levels at different stages of the product’s lifecycle: cell line genetic engineering, clone selection, nutrition (media, supplements, feed), and the process itself are all reasonable places to intervene The ... more »
    • Banked-Specimen Retrospective Studies
    • Jeffrey N. Gibbs
    • Many marketing applications for in vitro diagnostics (IVDs) need to be supported by clinical data This is especially likely for new analytes or new intended uses In some instances, the only means to gather the requisite data is by conducting ... more »
    • Catching Up to Multiplexing Technology
    • Elizabeth Lipp
    • There are many applications for multiplex assays, but we are only now realizing the full potential that this technology has to move compounds through the clinic more quickly and inexpensively Multiplexing is a life science lab research approach that performs ... more »
    • Protein Engineering Reaches New Frontiers
    • Nina Flanagan
    • Protein engineering has come a long way since the first monoclonal antibody was humanized in 1988 Novel techniques are improving safety and efficacy, as well as providing alternative delivery routes In addition, new methodologies are improving the characteristics of current ... more »
  • Columns

    • Spotlight on the FDA
    • Bruce Mackler
    • The Sameness Definition: FDA has always argued that an enantiomer, contained in a racemic mixture of an approved drug, is the same drug as in the original approved racemic mixture drug The FDA, in approving a Spectrum Pharmaceutical NDA and ... more »
    • Tackling Production Problems with Hydrogels
    • Carol Potera
    • Therapeutic proteins such as insulin or monoclonal antibodies are manufactured in bacteria, yeast, or mammalian cells Many proteins, however, cannot be expressed in these cells because they are too large or toxic to the cells that produce them The mission ... more »
    • Screening Membrane-Associated Targets
    • Anthony Shrout
    • Many diseases are initiated from molecular events that take place at the cell membrane level The membrane plays a critical role in cell communication and is the launching point for many vital signaling processes that occur within and between cells ... more »