Case Studies

Analytical & Microbiological Support to Clinical Research Unit

CASE STUDY: Analytical and Microbiological Support to Clinical Research Unit

Challenge:

Development and validation of analytical and microbiological methods for Intravenous (IV) products manufactured extemporaneously (EP) at Clinical Research Unit. Testing of isotopically labelled (14C, 13C, 15N) or unlabelled clinical EP products pre and post dosing to allow administration to patients within 24 to 48 hours.

Customer:

UK Clinical Research Unit (CRU), serving both small scale independent biotechs and large scale pharma.

Outcome:

Bioburden, Sterility, Bacterial Endotoxins, Assay/Impurities and Radiochemical Purity methods developed and validated against approved protocols prior to use in CRU Manufacturing Process Validation (Process Simulation Testing, Component Compatibility and Stability Studies) and testing of final Investigational Medicinal Products.

 

 

Micro and Analytical Case Study