The Biological Testing Facility, funded under contract with the Contraception Discovery and Development Branch (CDDB) (formerly the Contraception and Reproductive Health [CRH] Branch) fulfills a unique role in bridging the discovery of contraceptive targets to the development and approval of contraceptive products in the CDDB. It carries out biological safety and efficacy evaluations of new drugs with the goal of satisfying the regulatory requirements necessary to be able to introduce the new entities into clinical trials.
The facility screens submissions of drugs for classical endocrine and anti-fertility activity and establishes potency ratios for those that exhibit significant effects. It has also developed methods for determining the duration of hormonal activity following oral, subcutaneous, or transdermal administration.
The work done by the Biological Testing Facility allows researchers to assess the potential clinical utility of new compounds and formulations.
- In vitro efficacy studies: Test contraceptive drug candidates in enzymatic assays and cell based receptor-binding assays for their potential to bind and modulate activity of the androgen, progesterone, estrogen and glucocorticoid receptors.
- In vivo efficacy studies: Test contraceptive drug candidates for their potential androgenic (for example: extended Hershberger assays) and progestational activities (for example: Clauberg and extended Clauberg assays).
- Comprehensive efficacy studies: Fertility assessment, endocrine activity, toxicity, formulation, ADME (absorption, distribution, metabolism and excretion) profiling, stability, and pharmacokinetics of new chemical compounds, delivery systems and devices and other activities related to preclinical development to qualify products for testing in clinical trials for contraception.
- Development & validation of bioanalytical methods: Evaluates changes in hormones (i.e., LH, FSH, estrogen, progesterone, estrone, testosterone, Dihydrotestosterone) and microsomal stability as contraceptive drugs.
- Safety assessment studies: Acute, subacute, subchronic toxicology studies are conducted to evaluate safety of investigational compounds in the recovery of fertility and potential reprotoxicity using animal models including but not limited to rodents, rabbits, and non-human primates.
- Formulation development: Development of oral, injectable, and topical formulations and Good Manufacturing Practices (GMP) clinical manufacturing of drug products.