Scale-Up and Clinical Manufacture

The key to successful scale-up is in the proper understanding of the critical factors that influence product performance. These factors may arise from the API, excipients, or equipment and processing. Another important point is that the FDA (and other regulatory authorities) has certain expectations for scale-up; notably the 10X rule, i.e. a change in scale of manufacture beyond 10-fold requires that bioequivalence be reassessed. The application of the 10X rule is less rigid earlier in the development timeline. Generally, Phase I material is produced at the 1X scale and full production scale is 100X.

Clinical manufacture typically starts with the manufacture of the clinical supplies for Phase I studies, and continues through to eventual commercial launch and beyond, thus paralleling scale-up activities. Application of GMP during the drug development process should be flexible and appropriate to the progress of the project. Inappropriate, overly rigid application of cGMP, in particular during the very early stages of clinical development can increase the costs and timelines unnecessarily. The adopted level of GMP should be sufficient to ensure the product is suitable for human (or veterinary) use, and be commensurate with the progress of clinical development.

FinnBrit Consulting can advise clients on efficient scale-up and manufacture of clinical trials supplies.

Find us on FaceBook


All information published throughout is intended for information only, and does not contain any warranties, implied or otherwise.

Copyright © 2007 FinnBrit Consulting and Lenk Design. All rights reserved.

Site Map