Vaccine Development
Vaccines offer highly effective methods for controlling infectious disease. Vaccines have been recently extended to include applications in therapy for cancers, autoimmune diseases, and substance addiction.
Services from SRI Biosciences range from developing formulations to designing clinical protocols. Key to our vaccine development effort is our 10,000-square-foot animal facility with separate surgical suites and complete pathology capability. SRI also houses 12,000-square-feet of molecular and cell biology, microbiology, and virology laboratories with Biosafety Safety Level 3 (BSL-3) capabilities and Centers for Disease Control (CDC) select agent clearance.
SRI's experience and resources cover multiple types of vaccines (DNA, subunit protein, live and attenuated virus, peptide, and modified toxins) for conditions including infectious disease, toxins, and cancer. Our Vaccine Development Program also offers assay development and vaccine performance assessments. Services include:
- Good Laboratory Practice (GLP)-compliant safety toxicology and specialized biodistribution studies
- Good Clinical Practice (GCP) immunogenicity assays for samples from human clinical trials
- Good Manufacturing Practice (GMP) product quality assays (characterization and release assays, potency assays and stability assays)
SRI also offers expert consultation on vaccine development strategies and writes detailed product development plans. During the latter stages of the preclinical phase, a full package of regulatory services is available to prepare, assemble, review, deliver and follow up on IND submissions.
Services
Immunogenicity Measurement
- Antibody titers:
- ELISA
- Toxin, viral, and microbial neutralization assays
- ADCC activity
- Cell-mediated immune assays for T-cell activation and function
- ELISPOT for single cell activities
- Cytometric flow for multiple cytokines
- CD4 antigen driven proliferation
- CD8 cytotoxic activity
- Chemokine analysis
Efficacy Studies
- In vitro models (BSL-3 as necessary)
- In animal models (BSL-2)
GMP-compliant Vaccine Production
- Identify, qualify and manage subcontractors
- Develop a formulation
- Formulate, fill, and finish
- Conduct analytical characterization and stability studies
- Develop and perform potency assays
- Make antibody against manufacturing cell proteins required for release assay
Preclinical Safety Testing
- Consult on study design
- Perform GLP toxicology and safety testing
- Perform GLP biodistribution and integration studies
- Perform GLP reproductive toxicology studies
Regulatory Support
- Consultation on strategy and management of FDA interactions
- Submission of all meetings and follow-up documentation (e.g., pre-IND)
- Staff training for FDA meeting presentations
- Clinical protocol design
- Conduct of animal rule efficacy studies for biothreat agents
- Preparation and submission of all FDA documentation, including INDs, Clinical Investigators' Brochure, and Master Files
- GLP and GMP auditing services
