3rd CNE Seminar, DTU Science Park, Hoersholm, Denmark, November 8, 2018

Abstract:

Dr. Sven P. Jacobsson:

“Chemistry, Manufacture and Control (CMC), do’s and don'ts - the practice and requirements for Investigational Medicinal Product supply”

Successful supply of clinical trial materials relies on and is affected by decisions taken early in the development process, many in the pre-clinical phase.

Obviously, the active ingredient, regardless of being a small synthetic organic or a complex biological system such as cells or virus, needs to be manufactured consistently and by processes that allow going from small scales to large commercial supply. In doing so the processes and materials used and generated needs stringent testing/controls and systems for delivery of the API to the patient.

Despite the great diversity of contemporary medicines, CMC is applicable to all types of Investigational Medicinal Products and is based on some basic elements that will be discussed in the first part of the seminar – the Do’s.

The second part of the seminar focuses on the don’ts and challenges in CMC, based on real-life examples. Focus will be given to cases how to drive the development for small enterprise/virtual companies and how to interact with CDMOs and CMOs.

In the end of the seminar, there will be a Q/A session where you are welcome to bring in issues and questions from your own experience.