We have a proven track record of working in partnership with Pharmaceutical companies providing support services that are not core to their business, releasing people and management time to add value to the pharmaceutical drug development process. We offer both GMP testing and stability storage for Pharmaceutical companies.
Source Bioscience’s analytical division is a leading independent, MHRA approved (cGMP) contract research organisation that specialises in the provision of chemistry, manufacturing and control (CMC) laboratory services for all phases of drug development. We support the pharmaceutical research and development process from preclinical enabling studies for investigational medical products (IMPs), through the clinical research phases to batch release testing into the market place.
As part of our provision of the service we conform to current Good Manufacturing Practice (cGMP). Source Bioscience offer the following general testing routinely to the Pharmaceutical Industry.
Pharmaceutical Chemistry Testing:
• Stability storage & testing to ICH guidelines with 92 environmental chambers
• Method development and validation (ICH)
• Method transfer
• Clinical trial support (method development, batch release and stability)
• Pharmacopoeia testing (BP, USP, Ph.Eur, JP on raw materials, excipients, intermediates & finished products)
• Batch Release Testing to pharmacopoeia or customers methods
Pharmaceutical Microbiological Testing:
• Microbiological testing to pharmacopoeia and customers methods
• Total viable counts
• Specific pathogens
• Bioburden (Devices)
• Organism identification
• Bacterial endotoxins (LAL)
• QC Checks- environmental monitoring
Stability Storage Division
Source BioScience’s stability storage division has storage facilities based across two continents. With sites at Rochdale and Livingston in the UK, plus Tramore in Ireland and Atlanta and Los Angles in the USA. During our history, we have provided off site, controlled temperature and humidity storage for many of the blue-chip and top 20 global pharmaceutical companies.
We have multiple walk in rooms offering the ‘standard’ ICH conditions (5°C, 25°C/60%RH, 30°C/65%RH, 30°C/75%RH and 40°C/75%RH) as well as cabinets for bespoke and ‘unusual conditions’ to meet our client high expectations and requirements. We also offer frozen storage capabilities at -20°C, -70°C, -80°C and cryogenic storage at -196°C
Here at Source BioScience, we take the utmost care to ensure your samples are stored in a controlled, repeatable and secure environment and our sites encompass the following:
• Equipment logged using fully 21 CFR part 11 compliant data logging systems
• LIMS system introduced in 2015 to fully track sample management
• Back up diesel generator to ensure minimal disruption if power outages occur
• Controlled access to storage facility
• On-call duty engineers with critical spare parts held on site should components fail
• Various company accreditations including ISO:9001, GMP compliant, HTA (cryo-storage)
• Home Office approved to store controlled drugs (schedule 1 to 5)
• Site regularly audited by clients
• Proven track record within the pharmaceutical / medical / healthcare industries
• Can ship / return samples (controlled / frozen / refrigerated) throughout the world