3rd CNE Seminar, Technologiepark Basel, Switzerland, 3rd of May 2018
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 presentation – the Do’s.
The second part do the workshop is the reflection of Don’ts and challenges in CMC – with focus on some 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.