Coronavirus Update - 21st May 2020

We understand our customers concerns relating to the spread of COVID-19 and would like to assure you that we are located in one of the least affected areas of the UK and are open for business as usual.

We can confirm that we have complied with the government's guidance on managing the risk of COVID-19.

Download the certificate here

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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