Vaccine Development Program

Vaccines are one of the most effective methods of controlling infectious disease. More recently the use of vaccines has been extended to include applications in therapy for cancers, autoimmune diseases and substance addiction.

From developing a formulation to designing clinical protocols, our experienced staff works together with our clients to ensure that we provide all the vaccine- related services that they might need. Key to our vaccine development effort is our 10,000-square-foot animal facility with separate surgical suites and complete pathology capability. In addition, SRI houses 12,000-square-feet of molecular and cell biology, microbiology and virology laboratories complete with BSL-3 capabilities and 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 has full capabilities to carry out assay development and assess vaccine performance. These services include GLP Safety Toxicology and specialized biodistribution studies, GCP immunogenicity assays for samples from human clinical trials and GMP product quality assays (characterization and release assays, potency assays and stability assays).

In addition to our extensive array of laboratory services, SRI 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)

Assist with Production of GMP Vaccine:

• 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 in Animals

• Consult on study design
• Perform GLP toxicology and safety testing
• Perform GLP biodistribution and integration studies
• Perform GLP reproductive toxicology studies

Regulatory Support
Throughout each project, SRI provides complete and comprehensive regulatory support for its clients:

• Consultation on strategy and management of FDA interactions
• Submission of all meetings and follow-up documentation (e.g. preIND)
• 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

You Make the Call
For further information, contact our Client Services Team:
Toll Free: (866) 451-5998
Phone: (650) 859-6154
Fax: (650) 859-3041
Email: biosciences@sri.com

Contact Us

       Last Updated Jun 21, 2005