(138c) Applications (and Challenges) of Utilizing QbD, DOE and Other Process Tools In the Transfer of a Sterile Lyophilized Product From One Site to Another - Practical Perspectives

The FDA guidance on QbD has been in place for few years now, and one would anticipate that several manufacturers of medicinal products are applying it, or at least concepts from it, in the development and scale-up of manufacturing processes.  This presentation will describe how concepts of QbD and DOE were successfully used in the scale-up of a lyophilized product to manufacturing.  The presentation will also identify areas where these concepts of QbD and DOE encountered challenges in their application to yield anticipated results.  The presentation will highlight the importance of utilizing these tools with a systematic approach and having always in mind that no change is a simple change without proof.  Scale-up and transfer of manufacturing processes invlove the interplay of meriad factors, thus they need to be based on sound scientific and engineering principles and careful case by case risk analysis.  Often enough small changes in processing could result to un-anticipated results, and such changes might not have been fully explored for one or another reason in a careful QbD or DOE studies at the laboratory scale.  Robust manudacturing processes require application of science, engineering, and risk analysis tools on a continuous basis, from development all the way to and during commercial manufacturing.