【摘 要】
：
Recombinant protein therapeutics are routinely produced in mammalian host cell lines.The need for rapid entry of new molecular entities into clinical development requires rapid process development usi
【机 构】
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Oceanside Process Research & Development Genentech, Inc.USA
【出 处】
：
2008中国深圳蛋白质和多肽科学大会
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Recombinant protein therapeutics are routinely produced in mammalian host cell lines.The need for rapid entry of new molecular entities into clinical development requires rapid process development using productive cell lines.The first step in this process is usually the selection of a clone that exhibits high productivity and acceptable metabolite profiles while maintaining acceptable product quality attributes.A number of state of the art assays,including sequence variant analysis are used to determine product fidelity and consistency.Although a small amount of heterogeneity is generally acceptable for early phase clinical trials,a more homogeneous drug product is desired for advanced clinical trials and commercial manufacture to insure product consistency.Such analytic methods enable the identification of potential problems early in clinical development,which in turn helps prevent costly delays later.
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