Vaccine Development

CBI provides support for Vaccine development by offering an array of clinical testing services, assays and protocol development under GLP and 21 CFR guidelines. CBI's focus has been laboratory analysis throughout the process of manufacture of pre-clinical and early-stage (Phase I/II) clinical trial materials for vaccines cultivated by mammalian cell culture. Being fully integrated, CBI can work with a client from the initial research and development stage (concept) provide molecular biology support, cell culture, synthesis, and developing the genetically engineered cell lines, all the way through final biopharmaceutical product Biosafety testing and stability studies prior to distribution to clinical trial sites (clinic). CBI has worked with JVAP and DynPort Inc to develop assays and protocols for bulk vaccine testing to assure product safety.

CBI has developed a battery of tests and assays for product stability testing and safety testing, including assays for adventitious agents, viral plaque assays, PCR and PERT assays, TaqMan assays, HIV, HTLV, and HHV assays, as well as biochemical and sterility testing . Strategic alliances have been made with partners for testing in animal models. CBI has tissue culture facilities and provides primary cell culture and banking services for study support. Meeting FDA compliance and quality assurance guideline is imperative for final acceptance of the vaccine. CBI quality assurance and compliance group offer timely and professional support throughout the process. CBI has been audited by many different agencies and private companies and has a spotless record of compliance with FDA regulations.

CBI offers GLP sequencing of viral vaccines for FDA submission. Guidelines call for DNA sequencing data to be obtained at key points through the development and production process.

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Commonwealth Biotechnologies, Inc.
601 Biotech Drive, Richmond, VA 23235
800-735-9224 (800-RELY-CBI) FAX: 804-648-2641
email: [email protected]