Manufacturing and Nonclinical Studies Support for the Development of Therapeutic Biotechnology Products for Neurological-related Disorders

The National Institute of Neurological Disorders and Stroke is executing a Master IDIQ established September 28, 2022, providing current Good Manufacturing Practices (cGMP) manufacturing and Good Laboratory Practice (GLP) nonclinical support services for therapeutic biologics development supporting NIH programs including the Blueprint Neurotherapeutics Network Biologics program, the Ultra-Rare Gene Therapy program, and the Helping to End Addiction Long-term Pain Therapeutics Development Program. The ordering period extends through September 29, 2030, leaving approximately four years and two months of ordering authority remaining.

The vehicle carries a shared ceiling of $149.2 million with thirteen task orders awarded to date. Activity has been moderate: four orders in 2022, three in 2023, five in 2024, and one in 2025. The combined task-order potential value stands at $59.9 million, with $30.8 million obligated to date, representing 52 percent of combined potential value. Task orders are concentrated among three primes. Battelle Memorial Institute dominates with eight orders totaling $39.1 million in combined potential value, representing 65 percent of the portfolio. Advanced Bioscience Laboratories, Inc. holds four orders worth $20.7 million combined potential value, approximately 35 percent. Leidos, Inc. holds one order with minimal value. All thirteen task orders carry no set-aside designation.

Customer concentration is split across three NIH institutes. The National Institute on Drug Abuse funds five orders with the largest combined potential value at $34.7 million, roughly 58 percent of the portfolio. The National Institute of Neurological Disorders and Stroke funds six orders with $8.5 million combined potential value. The National Center for Advancing Translational Sciences funds two orders with $16.7 million combined potential value.

Task-order work spans GLP toxicology and pharmacokinetic studies in rodents and non-rodents, cGMP manufacturing of viral vectors and plasmids, bioanalytical assay validation, dose-range finding studies, and in vitro drug-drug interaction testing. Ceiling values on recent orders range from approximately $1 million to $14.1 million, with durations spanning 18 to 36 months. Pricing is cost-plus-fixed-fee.

Good Manufacturing Practices (cGMP) manufacturing and Good Laboratory Practice (GLP) nonclinical (preclinical) support services to support translational development of therapeutic biotechnology products (Biologics) for NIH drug discovery and development programs.