Delivering a vaccine to market is a complex and time-sensitive process, with only a limited window in which to ensure that your vaccine is both viable and profitable. Charles River Biopharmaceutical Services (BPS) can help you expedite your vaccine manufacturing from early development through preclinical and clinical trials by providing you with expert regulatory guidance, quality safety testing and manufacturing.
The production and manufacturing of vaccines from cell lines has many unique complexities that can potentially affect the safety of a vaccine. Accordingly, biosafety testing is essential to ensure that cell lines used for vaccine production are free from bacterial, fungal, mycoplasma, and adventitious viral agent contamination. Charles River provides current Good Manufacturing Practice (cGMP) manufacturing and testing of vaccines for early-phase clinical trials and potency assays (lot release) of commercial product. We also have extensive experience manufacturing vaccines in both cell culture and specific pathogen-free (SPF) egg-based systems. Our experience allows us to predict and eliminate potential pitfalls early in development while ensuring compliance with all applicable international regulatory standards.
Testing
Characterization and safety testing of vaccines is an essential part of the safety concept for cell-derived biopharmaceutical products. The master viral seed (MVS) and master cell bank (MCB) used in the manufacture of a vaccine must be intensively characterized, and their biosafety must be demonstrated along with the raw materials and components. Following fill and finish, the vaccine must also go through the same rigorous tests to demonstrate purity and safety. Biochemical, molecular biological and virological testing methods are all included in our wide range of testing services.
Services
Related Information
Webinar Replay - Challenges in the Development, Production and Release of Viral Vaccines (May 2011)
To check which of our BPS facilities offer vaccine safety testing services, click here. For additional information, contact us at askcharlesriver@crl.com.