Viral clearance studies are crucial in ensuring that a marketed product is safe for use in humans. As a manufacturer of biopharmaceuticals, you are required to assess that their manufacturing process has adequate capacity to remove any actual or potential adventitious agent that may be present.
Covance Biopharmaceutical Service Division has extensive experience in performing regulatory compliant viral clearance studies that have been accepted by regulatory authorities worldwide.
Depth of experience:
- With 15 years experience, over 2000 validation studies performed
- A wide variety of products produced by recombinant technology, hybridomas, human and animal plasma as well as products intended for xenotransplant
- A broad range of viruses and detector assays available for use. Both infectivity and QPCR assays are available
- 10 dedicated tissue culture and virology suites
- Fully validated Category 3 facility
- Dedicated laboratory allocated to you as well as all necessary services to complete the study
Client interface and commitment to quality:
- Dedicated staff provides extensive consultation and advice on scientific, regulatory and planning aspects of the forthcoming study
- Effective communication is established right from the beginning of an inquiry. We ensure careful planning and design as the start of a successful study
- Dedicated Quality Assurance Department, operating independently of operational units, inspects and audits all aspects of study performance, for factual integrity, GLP compliance, adherence to SOPs and P&Ps