Coronavirus Update - 07th August 2020

We would like to take this opportunity to thank our clients and staff for their continued support over this period of restricted movement. 

We remain open for business as usual and have started welcoming limited numbers of visitors to site

We fully comply with all government guidance on minimising the risks of COVID-19 and have published our risk assessment here

Our work and case studies

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