Genentech, FDA work on quality pilot

Genentech has submitted--and had accepted--two proposals to an FDA pilot program intended to test quality by design concepts. The filings are part of an effort in which Genentech is working with the FDA on a case study designed to illustrate key principles of the quality by design manufacturing concept. Such concepts are part of the FDA's Critical Path Initiative, based on guidance from the International Conference on Harmonization.

According to Lynne Krummen, senior director for regulatory matters at Genentech, speaking at the recently concluded BIO show, the FDA Quality by Design pilot project is a "relatively immature effort at this point." For example, such terms as "critical quality attribute" and "critical process parameter"--even the key term, "design space"--are still being defined. There is of course some latitude in what such terms will ultimately encompass; current efforts are geared toward finding the outer boundaries.

The proposals Genentech has submitted to the FDA pilot concern two new biologic license applications. One challenge she notes concerning the pilot is that "execution is critical-we cannot jeopardize the approval timeline." Another complicating factor is that Genentech has planned simultaneous filings in the U.S., the European Union and many ICH regions.

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