Coronavirus Update - 14th October 2020

Despite the recent rises in Covid-19 cases throughout the UK and Europe, Arcinova remains open for business at full capacity as we have done throughout this pandemic. As the situation continues to evolve, we will keep all our customers and stakeholders informed of our activities through this web-page which is updated on a regular basis.

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

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