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.
CED Life ScienceThe CED Life Science Conference will be attended by Masha Kononov, Senior Director Emerging Pharma US and Gail Frey, Senior Director Key Accounts US.
CED Life ScienceDates: 26th - 27th FebruaryLocation: Raleigh, NC
Drug Delivery & Formulation SummitThe DDF Summit 2019 will be attended by Dr. Nathalie Huther, Business Development Manager Europe.
Drug Delivery & Formulation SummitDates: 11th - 13th MarchLocation: Berlin, Germany
BioEurope SpringBioEurope Spring will be attended by Dr. Nathalie Huther, Business Development Manager Europe.
BioEurope SpringDates: 25th - 27th MarchLocation: Vienna, Austria