Preclinical Services for Biopharmaceutical Product Development

Award Date 9/1/2016
Last Date To Order 8/31/2026
Shared Ceiling $159M
Contract Type
Master IDIQ
Predecessor
Not listed
Successors

The Preclinical Services for Biopharmaceutical Product Development Master Indefinite Delivery/Indefinite Quantity (IDIQ) contract is designed to support the development of therapeutic products targeting critical public health challenges, with a specific focus on infectious diseases, bioterrorism agents, drug-resistant pathogens, and emerging health threats. The contract encompasses a comprehensive suite of preclinical product development services required for Investigational New Drug (IND) applications, Biologic License Applications (BLA), and other regulatory submissions to the Food and Drug Administration. These services are intended to advance the development of diagnostic and therapeutic interventions for human infectious diseases through a proactive and product-oriented approach.

Task orders under this vehicle demonstrate a consistent pattern of cost-plus-fixed-fee and firm fixed-price contracts, with values ranging from approximately $8,000 to $1.2 million. Key contractors include Resilience Government Services (Nanotherapeutics Inc.), Dynport Vaccine Company LLC, and Advanced Bioscience Laboratories, Inc., who have performed work primarily for the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health. The task orders typically involve specialized scientific services such as cell line evaluation, analytical method development, manufacturing process optimization, stability testing, and master cell bank production. Performance locations have included facilities in Maryland, and none of the reviewed task orders utilized small business set-aside designations. The contract vehicle is set to remain active until August 31, 2026, with a total shared ceiling value of $159,444,814.

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