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The High Bar for Gene Therapy CMC

White Paper The High Bar for Gene Therapy CMCHow drug developers can step up to meet regulatory expectations for gene therapy chemistry manufacturing and controls. After well publicized stumbling blocks in the late-90s, vigor was restored to the gene therapy field in...
White Paper

Process Validation and Regulatory Review in the Age of Expedited Approval Drugs

process validation for expedited approval drugs

Expedited approval drugs have profoundly changed the thinking and approach to Process Validation and other CMC activities. When working on the development of an expedited approval drug, Chemistry, Manufacturing and Controls (CMC) data needs to be generated in about half the time of the traditional process.

Of course, an expedited approval classification does not mean that the drug developer can do less. In order to meet these accelerated timelines, analytical methods creation and product and process characterization needs to start sooner, and the process needs to be handled differently.

This paper explores those dynamics and offers some revised approach suggestions.

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