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Spring Valley Laboratories, Inc.

PO Box 242

Woodbine, MD 21797 US


Spring Valley Laboratories, Inc. Services:

FDA, 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 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. In vivo product release tests that meet cGMP requirements and any other requirements you may have.

General Safety Test for Biologics - U.S.P./CFR 610.11
Abnormal Toxicity Testing - E.P.
Rabbit pyrogen test - U.S.P.
Rabbit Pyrogen Test - E.P.
in vivo Adventitious Agent Testing - 21 CFR 630.35, PTC/CBER/1993, and ICH (Q5A) documents
adult mice
suckling mice
embryonated hen's eggs
other species if needed