BIOLOGICAL TESTING FACILITY - FORMULATION, SUPPLY, AND STABILITY TESTING OF CONTRACEPTIVE DRUG CANDIDATES FOR CLINICAL TESTING

Sri International, Menlo Park CA

Investigators

Abstract

The Biological Testing Facility (BTF) is designed to permit rapid evaluation of new compositions of matter, drug formulations, delivery systems, and devices for contraceptive and endocrine activity. The BTF has the capability of formulation, clinical batch preparation and release and continued stability testing of drugs that are evaluated in clinical trials. The BTF provides overall project management and the capabilities to support all phases of preclinical activities and development of contraceptives: these are but not limited to in vitro and in vivo assays, absorption, distribution, metabolism, excretion and toxicity (ADMET) and pharmacokinetic (PK) profiling, animal activities and studies, manufacture of active pharmaceutical ingredients (APIs), process and product development, formulation, clinical lot production, preclinical enabling studies and associated tasks leading to the filing of investigational new drug (IND) applications. Compounds provided or formulated by the BTF for clinical or IND enabling evaluation are prepared under Good Manufacturing Practices (GMP) to allow clinical evaluation in the CDDB Contraceptive Clinical Trials Network (CCTN). The BTF has been working with the CORs (for the Chemical Synthesis Facility and the CCTN) and the investigators in the CCTN to develop and test the appropriate formulations for clinical batches. The next study for each candidate drug is dependent on timely receipt of clinical batches to begin the process of recruitment and enrollment. Drugs that are currently in ongoing clinical trials require stability testing of the clinical formulations. The task will support all preclinical activities as described in the Background but not limited to supply and/or formulation services designed to develop NCEs/APIs, for preclinical or clinical evaluation, in appropriate vehicles and appropriate concentrations that will be suitable for use as a contraceptive product. The agents may be developed in house or via appropriate subcontract facilities. Formulations may be administered orally, intramuscularly, transdermally or other routes of administration acceptable for clinical trials. The formulated products will be characterized with respect to pharmacokinetics, in vivo activity, safety, stability and other preclinical evaluations pursuant to filing and maintaining an IND that would support batch release and testing in clinical trials.