Drug Manufacturing and Formulation Program (DMFP)

The National Institutes of Health established a Master IDIQ on January 15, 2015, to support development and manufacture of drug dosage forms (parenteral, oral solutions, tablets, capsules, ocular delivery systems) for small molecule candidates in preclinical efficacy studies, Investigational New Drug enabling studies, and clinical trials; ordering closed on January 14, 2025, and the vehicle is no longer accepting new task orders.

The vehicle spans process development and preparation of active pharmaceutical ingredients, pre-formulation and formulation studies, physical and chemical characterization, analytical method development and validation, stability studies, drug product manufacturing, packaging, storage, quality control, regulatory documentation, and distribution. Work flows to research projects sponsored by the National Institute of Neurological Disorders and Stroke and the National Institute on Drug Abuse within NIH.

Curia Global Inc. and Mriglobal dominate the vehicle. Curia holds 13 of 20 task orders and $16.4 million of the combined potential value; Mriglobal holds 7 orders and $13.4 million. No other contractors share the awards. Funding splits evenly between the two customer institutes: the National Institute on Drug Abuse placed 12 orders worth $14.6 million combined potential value, and the National Institute of Neurological Disorders and Stroke placed 8 orders worth $15.2 million. All task orders are unrestricted competitive awards with no set-aside designation.

The vehicle generated 20 task orders over 11 years, with peak activity in 2019 (four orders). Recent ordering has slowed to two orders annually in 2023 and 2024. Combined task-order potential value stands at $29.8 million; $21.9 million has been obligated, representing 73 percent utilization. Recent task orders range in ceiling value from $1.28 million to $5.1 million, with performance periods typically extending three to four years. Most task orders are structured as Cost Plus Fixed Fee or Cost Plus Award Fee arrangements.

Since ordering is closed, pursuit of new work requires reinstatement of the vehicle or identification of successor vehicles within the BPN (Biomedical Primate Network) family at NIH.

This Master IDIQ, under the auspices of the NIH, National Institute of Neurological Disorders and Stroke (NINDS), and as part of the BPN, supports the development and manufacture of dosage forms (e.g., including and not limited to parenteral, oral solutions, tablets, capsules, and ocular delivery systems) of small molecule drug candidates suitable for administration in preclinical efficacy studies, Investigational new drug (IND) enabling studies, and clinical trials. Work under the proposed contract will include process development and preparation of active pharmaceutical ingredients (API), pre-formulation and formulation studies, physical and chemical characterizations, analytical method development and validation, stability studies, drug product manufacturing, packaging, storage, quality control, regulatory documentation, and distribution of the drug products.