Chemistry, Manufacturing & Control
The dynamic process whereby the global pharmaceutical industry is regulated results in a regulatory landscape where the drug development goal posts continuously move. This rings true for CMC development and drives the demand for independent, up-to-date and practical advice which can be integrated into drug development programs.
Kinesis Pharma’s CMC department provides advice on CMC development strategy which strikes a balance between the technical and regulatory demands of each drug development program and the goals of the sponsor; resulting in solutions which are fit for purpose.
CMC development aims to characterize the relationship between the quality attributes of the candidate medicinal product and its performance, whether it’s a new chemical entity (NCE)/small molecule or new biological entity (NBE)/biological, and ultimately to develop a robust manufacturing process which ensures the drug product meets the quality requirements for its intended use i.e. content/potency, purity and identity.
"Solving CMC challenges shifts the risk profile favorably"
Contact detailsAnnemiek Stijnen, Ph.D.,Senior Director Chemistry, Manufacturing & Control Tel: +31 76 54 80 639 Mob: + 31 6 22 55 25 36 Email: Annemiek.Stijnen@Kinesis-Pharma.com |
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