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Clinical trial support

Clinical trial support
Prior to the initiation of a clinical trial with cell and gene therapy products a lot of questions relating to the production of the trial medication need to be answered. These include:

»Is your starting material suitable for GMP production?
»Is GMP material needed for preclinical studies?
»Is the process of production GMP compliant or does an optimized process need to be developed?
»How long will it take from start of GMP production to the release of the product?
»When should GMP production start?
»Which documentation has to be established prior to
and concomitant with GMP production?


We can help you to answer these questions.


Production of clinical trial medication
We offer integrated manufacturing services for your clinical trial material ranging from cell and vector banking to QP release of your product. Please refer to our pages on Manufacturing for further details.

Molecular patient monitoring
Gene therapy trials allow/require a larger number and wider range of assays on patient samples than traditional drugs. We offer:

»Safety testing on samples from clinical trial
subjects (e.g. test for replication competent
retroviruses)
»Efficiency testing on samples from clinical trial
subjects (e.g. quantification of gene-modified cells)