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October 15, 2007 (Vol. 27, No. 18)

Biologics Force Changes in Stability Testing

Multiple Approaches Are Necessary to Ensure Complete Information

  • The introduction of biologicals into our drug armamentarium is complicating stability testing. For these complex molecules neither physicochemical data nor bioassays alone provide the complete picture, so both are usually required. “You can’t tell everything about molecules by normal physicochemical techniques, especially higher-order structures,” notes C. Jane Robinson, Ph.D., ...

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