Quality by Design: A CMO's Perspective On Gaining Knowledge Faster And Better

By Clinton Weber, Ashok Kumar, Roland Ashton, Lisa Joslin, James Schmid, And Michael Larson

Although the phrase “QbD” has been thought of as a new or borrowed concept and discussed in terms of feasibility, many CMOs have been using these con-cepts, albeit perhaps not in a well-planned, cohesive manner. Now the discussion has turned to breaking down the reality of a QbD strategy. Implementing the infrastructure of a QbD approach to Process Devel-opment involves formalizing the commitment and the strategy and integrating execution into Quality Sys-tems. The end result is a road map for the develop-ment of the product from the very beginning.

The purpose of this paper is to present a scenario based upon a real case study, where the project deci-sion making followed a “traditional” approach to de-velopment and commercialization, which in turn caused longer development timelines and increased program costs. In this example, the traditional ap-proach involved minimizing development studies to keep costs down, waiting for clinical data to perform any further optimization, and then performing a long series of univariate characterization studies to com-plete the information required for a submission. In contrast to this approach, a second product with a different client was planned and scheduled against a timeline with a built-in strategy to gain knowledge of the process more quickly. The predicted result not only lowers the risk of the manufacturing commercial-ization effort, but should also be a significant time savings. For a CMO, occupying space in Manufactur-ing or even on the bench costs money; thus, time is money in the truest form.