Vaccine

Vaccines are medicinal agents intended to elicit an immune response by increasing antibody production and/or specific T-cell responses. With time, vaccines have evolved from conventional prophylactic uses to more complex and novel therapeutic products. These advances require careful scientific consideration of a vaccine’s properties and its clinical use.

IND Gantt Chart for Vaccines

BI-000349

Charles River has effectively supported the vaccine industry for decades with our unique range of products and related services. Our global network of scientific, technical and regulatory experts provide vaccine developers with the right expertise early in the development process to boost productivity, efficiency and profitability and get the safest and most effective vaccines to market.

It is important to research and eliminate unsuccessful programs through in vitro and in vivo techniques in order to find the best lead candidate. With our unmatched knowledge of animal models, safety testing and immunology, Charles River can assist in selecting the most promising vaccine candidates and provide the information our clients need to develop better vaccines.

Related Products & Services

Charles River has the breadth of services and expertise to help clients successfully initiate and complete critical phases of preclinical drug development by designing, performing and documenting safety tests that meet the appropriate regulatory requirements before and after clinical trials begin. We can also assist with a vaccine development strategy that covers early development through to market.

Our capabilities include vaccine and vector safety studies in multiple species via multiple dose routes. These studies provide the efficacy and safety testing data required for vaccines and other anti-infective agents. We design and perform studies in CDC-approved quarantine facilities with Biosafety Level (BSL)-2 upgrade ratings to fulfill our client’s preclinical regulatory needs in a Good Laboratory Practice (GLP)-compliant environment.

In Vivo Studies Products & Services

Laboratory Support Products & Services

Charles River offers multiple products and services in support of the development, manufacture and analytical testing of vaccines. We offer endotoxin testing for product release and embryonated, specific pathogen-free (SPF) eggs for the production of veterinary and human vaccines and vaccine testing.

We have experience in the manufacture of live and attenuated viral vaccines in both cell- and egg-based expression systems under current Good Manufacturing Practice (cGMP) requirements for both preclinical studies and early-phase clinical trials. We also offer GMP testing of clients’ products from release of cell banks and viral stocks to the release of bulk and final vaccine product.

Manufacturing SupportTesting Support
SPF eggs that meet USDA and EU Pharmacopoeia requirementsEfficacy/challenge studies
Embryo-based primary cell productsAdjuvant assessment
Bulk antigen productionIn vivo potency assays including lot release of clinical and commercial final products
Avian pathogen testing includes 9CFR and product evaluation studiesImmunopotency assays
Antigens, antisera and poultry diagnostic reagentsIn vivo biosafety testing
cGMP cell banking and characterizationPyrogenicity/endotoxin/monocyte activation test (MAT)
Virus seed preparation and testingDose-ranging studies
Pilot scale virus manufacturingStability studies

Charles River has an international network of scientific experts in the areas of discovery, immunology, pathology and GMP vaccine safety, efficacy and release testing. Our regulatory and scientific advisors have both FDA and pharmaceutical industry experience and consult with clients to ensure the appropriate study plans are developed. If questions arise during testing, our team will provide support in developing the most effective path forward.