Vaccine Development Testing from Discovery to Production
One of the key challenges of an effective vaccine is understanding if the immune system correlates to the required level of vaccine protection needed(1,2). Such understanding leads to improvements in antigen and adjuvant selection and the design of better vectors; all of which contribute to the success of a vaccine candidate, while also not forgetting the appropriate safety testing. To do this, it requires appropriate preclinical models, testing methodologies, and necessary immunology tools be available.
Charles River has a long history going back for decades supporting the vaccine industry with a specific and 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.
(1) The current challenges for vaccine development. Oyston, Robinson J Med Microbiol. 2012 Jul;61(Pt 7):889-894. doi: 10.1099/jmm.0.039180-0. Epub 2012 Feb
(2) Challenges and responses in human vaccine development. Stefan HE Kaufmann and all. Current Opinion in Immunology Volume 28, June 2014, Pages 18-26
- Discovery to Lead Candidate Optimization
- Safety Assessment
- Manufacturing Services
- Regulatory and Scientific Support
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, infectious diseases, 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 testing 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 for Vaccine Testing
Vaccine development follows a strict regulatory pathway, of which the safety assessment is a critical component. Careful consideration of study designs and interpretation of subsequent data is important. The type of studies conducted depend on the vaccine type. There are two keys aspects that relate to vaccine testing:
• The non-clinical toxicology assessment (Module 2 of a CTD dossier)
• The product safety characterization (Module 3, quality and CMC), required as part of a quality lot release assessment.
It’s important to select a laboratory that can provide key technical expertise and experience in handling these types of products to run these studies successfully and support critical data interpretation.
Module 2 – Non-clinical studies
• Safety and efficacy
• Local / systemic studies
• Vector shedding studies & biodistribution
• Reproductive toxicology
Module 3 – CMC quality and lot release test
• Potency and dose response
• Neurovirulence safety testing
Supporting scientific vaccine testing expertise include the following
• Assessment of neutralizing antibodies - nAb
• Measurement of the humoral and cellular immune response by ELISPOT and by flow cytometry (mainly looking at the activation of specific cell types)
• Measurement of specific biomarkers (e.g.: CRP, cytokines)
• Infectivity and titer for vaccines
Laboratory Support Products & Services
Charles River offers multiple products and services in support of the vaccine 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 Support||Testing Support|
|SPF eggs that meet USDA and EU Pharmacopoeia requirements||Efficacy/challenge studies|
|Embryo-based primary cell products||Adjuvant assessment|
|Bulk antigen production||In vivo potency assays including lot release of clinical and commercial final products|
|Avian pathogen testing includes 9CFR and product evaluation studies||Immunopotency assays|
|Antigens, antisera and poultry diagnostic reagents||In vivo biosafety testing|
|cGMP cell banking and characterization||Pyrogenicity/endotoxin/monocyte activation test (MAT)|
|Virus seed preparation and testing||Dose-ranging studies|
|Pilot scale virus manufacturing||Stability 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 for your vaccine development.