Analytical & Microbiological Support to Clinical Research Unit
CASE STUDY: Analytical and Microbiological Support to Clinical Research Unit
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.
UK Clinical Research Unit (CRU), serving both small scale independent biotechs and large scale pharma.
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.
Bio SpainBioSpain 2018 will be attended by Nathalie Huther, Business Development Manager Europe.
Bio SpainDates: 25th - 27th SeptemberLocation: Seville, Spain
BioForwardThe BioForward event will be attended by Nathalie Huther, Business Development Manager Europe.
BioForwardDates: 4th OctoberLocation: Birmingham, UK
CPhI WorldwideCPhI Worldwide will be attended by Nathalie Huther, Business Development Manager Europe. Nathalie will be located at the DIT stand: 9J40
CPhI WorldwideDates: 9th - 11th OctoberLocation: Madrid, Spain