Spring Valley has experience in performing FDA and OECD GLP-compliant safety evaluations of DNA, protein, peptide, and attenuated live organism vaccine candidates. To evaluate these candidates, Spring Valley has conducted single and repeat dose, local reactivity, ocular irritation, reproductive, and developmental toxicity studies in various species using various routes of administration. Capabilities exist on-site to perform serum chemistry and hematology determinations and necropsy, pathology and histopathology evaluations. A board-certified veterinary pathologist supervises these activities. An independent Quality Assurance Unit ensures compliance with GLP regulations. A secure archive facility on-site is available for all study documents.
Spring Valley Laboratories is committed to assisting you in achieving all your goals in developing a new vaccine product and in continuing to support you as the product life cycle unfolds. To this end we offer the following in vivo product release tests:
General Safety Test for Biologics – U.S.P./CFR 610.11
Abnormal Toxicity Testing – E.P.
in vivo Adventitious Agent Testing – 21 CFR 630.35, PTC/CBER/1993, and ICH (Q5A) documents