Preclinical Services for Biopharmaceutical Product Development

The National Institutes of Health awarded this Master IDIQ for preclinical services supporting biopharmaceutical product development on September 1, 2016, with ordering authority expiring August 31, 2026 — approximately one month remaining to place new orders against a $159.4 million ceiling.

The vehicle funds development activities required for Investigational New Drug applications, Biologic License Applications, and related FDA submissions, including analytical method development, manufacturing process scale-up, cell-line characterization, stability testing, and cGMP master cell bank production. All eight task orders awarded to date are unrestricted and funded by the National Institute of Allergy and Infectious Diseases.

Ordering activity has been sparse and declining: four orders placed in 2016, two in 2017, one in 2022, and one in 2023, with no new awards in the past two years and ten months. The combined task-order potential value is $3 million, fully obligated. Resilience Government Services, Inc. holds the largest share with three orders valued at $1.6 million combined, followed by Dynport Vaccine Company LLC with two orders at $1.2 million combined. Advanced Bioscience Laboratories, Inc. and Catalent Maryland, Inc. each hold one order. No contractor dominates significantly; the top two primes account for roughly 93% of potential value.

The recent task-order record reflects two major effort areas. The largest recent order, to Resilience Government Services, Inc., funded development of analytical methods and manufacturing processes for an LNA14 product with $799.8 thousand obligated through December 2024. The second-largest, to Dynport Vaccine Company LLC, covered evaluation and production of a monoclonal antibody master cell bank at $1.2 million through August 2023. Earlier orders between 2016 and 2018 addressed stability testing and management functions at smaller values, with most now completed.

The vehicle's contract type is Cost Plus Fixed Fee for the two largest recent orders and Firm Fixed Price for earlier efforts. Given the imminent expiration date, no successor vehicle is noted in the source material.

The development and introduction of new therapeutic products against potential agents of bioterrorism, drug-resistantpathogens, emerging and re-emerging infectious diseases, as well as infectious diseases prevalent in resource-limited countries remain a high public health priority. To assist in filling these public health gaps, the NIAID requiresa nontraditional, proactive, and product development-oriented program to provide preclinical product developmentsupport for promising biopharmaceutical therapeutic candidates for human infectious diseases or diseases caused byinfectious agents. The suite of services included in this contract will encompass those activities commonly associatedwith the development of biopharmaceutical products for treating or diagnosing infectious disease that are required forInvestigational New Drug (IND) application and/or Biologic License Application (BLA) and/or other FDA submissionsincluding 510(k) application and Investigational Device Exemption (IDE) application.