A vaccine development program is unique and requires specialized regulatory and assay development expertise. As you tackle your vaccine development, there may be certain areas that are not within the core capabilities of your company and you need to turn to outsourcing for these studies. Charles River’s scientists draw on years of experience in vaccine study design and execution and continually partner with clients to customize programs to meet the needs of a wide range of prophylactic and therapeutic vaccine companies. Services offered by Charles River include:
|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|
Looking specifically at in vivo studies, the availability of suitable animal models is an essential component in the development and final lot release of many human and veterinary infectious disease vaccines. When performing vaccine efficacy and safety assessment studies based on these models, a number of critical factors need to be discussed with your outsourcing provider including:
- Use and availability of specific pathogen-free (SPF) animals.
- Availability of suitable challenge material that is robust, stable, and of clinical relevance.
- Biosecurity and housing environment of animals both prior to and during studies.
- Commitment to performing the study to compliance and continuous improvement in animal welfare, the 3 Rs, and humane care.
- Skills and accuracy of the animal scientists conducting the study in administering vaccines and challenge materials and in performing the ongoing clinical assessments and study measurements.
- Knowledge and implementation of quality standards (e.g., GMP, GLP), including record keeping, data integrity, and training, in place at the institution performing the study.
Ferrets (Mustela putorius) and cotton rats (Sigmodon hispidus) are the primary animals used in vaccine development for infectious respiratory diseases such as influenza, RSV, and hMPV. The ferret and cotton rat animal models are unique and come with their own challenges in terms of housing, handling, and dosing in addition to the above considerations. These animals must be kept in a calm and stress-free state to ensure optimum study conditions and reduced study variability. Charles River has the expertise and purpose-built facilities to care for these animal models and has invested in the training and availability of specialized technical staff to support respiratory disease vaccine research and development making sure you achieve the results you need in the timelines you require.
Our staff are always available to discuss and develop new study designs and to work with clients to implement effective development programs. To schedule time to speak with our scientists, contact us at [email protected].