BPN PROJECT BPN-36938

Albany Molecular Research, Inc., Albany NY

Investigators

Abstract

The National Institutes of Health (NIH) established the Blueprint Neurotherapeutics Network (BPN) to accelerate the process of discovering and developing new drugs. The BPN supports, through grants and contracts, every step of the drug development process from validated hits through early clinical trials. The Drug Manufacturing and Formulation Program (DMFP), a component of the BPN, conducts the development and manufacture of dosage forms of small molecule drug candidates suitable for administration in preclinical efficacy studies, Investigational New Drug (IND) enabling studies, and clinical trials. Contractors conduct process development and preparation of active pharmaceutical ingredients (API), pre-formulation and formulation studies, analytical method development and validation, stability studies, drug product manufacturing, packaging, labeling, storage, and distribution of the drug products. The work is conducted in accordance with Current Good Manufacturing Practices (cGMP) regulations as required and where appropriate in accordance with Good Laboratory Practice (GLP) regulations. Data and documentation are prepared in a form acceptable to the Food and Drug Administration (FDA) for inclusion in a Drug Master File (DMF), IND application, or New Drug Application (NDA). The mission of the National Institute of Neurological Disorders and Stroke is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease for all people.