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Biotechnology Services
Services |
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Cell Bank Production Services
Covance has over 18 years experience in performing regulatory compliant biosafety services that have been accepted by the FDA and European regulatory authorities. Covance has a comprehensive service offering in cGMP master (MCB) and working (WCB) cell bank generation and in cell line biosafety testing.
This service is ideal if you need to find a complete cell banking and safety testing package from a single trusted laboratory, require your cell banks to be prepared independently from a contract manufacturer, or wish to expand your in-house availability. We always strive to understand your needs and provide you with an integrated, high-quality and solution-driven service.
Covance prepares all cell banks in classified and validated clean room suites complemented by comprehensive cleaning and environmental monitoring programs. Our approach is designed for a smooth process transfer from seed stock to cell bank. Covance can produce preliminary MCBs suitable for cGMP pilot studies and the production of early phase material or MCBs and WCBs for producing material in conjunction with a late phase study or in-market supply. All personnel involved in the production of cell banks work under an operator and checker system to safeguard against errors. All operators are qualified on a routine basis for continued competency.
Why work with Covance
- World Class Expertise
- Quality: Covance is one of the first CROs who obtained an MHRA (Medicines and Healthcare products Regulatory Agency) manufacturing license for cGMP cell bank production.
- Covance's team has many years of experience producing a variety of cell banks for major biotech, biopharmaceutical and manufacturing companies.
- World Class Efficiency
- Track Record: Covance has a zero contamination record due to human errors.
- State-of-the-Art facility
- Solution-based services: Covance offers a comprehensive portfolio of services to ensure that you have the best qualified cell banks to produce your final biopharmaceutical products.
Facility and Equipment
- Facility fully validated according to cGMP and complemented by a comprehensive validation master plan (VMP) for services, processes and equipment
- Two-stage, independent, secure and controlled access to the facility for named personnel only
- Dynamic environmental contaminant monitoring of facility and operators during critical steps, backed up by static environmental contaminant monitoring of the facility following cleaning procedures
- Disinfectant rotation schedules performed routinely
- Constant positive pressure throughout facility using terminal HEPA (high efficiency particulate air) filters with partial re-circulation
- Aseptic manipulations performed in a vertical laminar airflow cabinet:
- grade A (class 100) with a background
- grade C (class 10,000) environment
- All critical equipment monitored and alarmed locally and remotely to a 24-hour service
For more information, click here to download our Cell Banking and Biosafety Testing service brochure. |
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