Biologics manufacturing and nonclinical services

Active Awarded Last action

Contract number
75N95022D00021
Awardee
Awarding agency
Task orders
8 $19,758,367 obligated

Award facts

Opportunity
  • 75N95022R00013 Solicitation number
Combined order value
  • $19,849,505 Current, with exercised options
  • $39,145,050 Potential, with all options
Last date to order 51% complete
IDV ceiling 13% used
$149,200,000.00
Award type
Multiple award
Who can order
Only the awarding agency
Funding agency
National Institute of Neurological Disorders and Stroke National Institutes of Health, Department of Health and Human Services
Set-aside
No set-aside
Competition
Full and Open Competition · 3 offers Negotiated Proposal / Quote
Pricing
Order Dependent (IDV only)
Legislative mandates

Award details come from SAM.gov/FPDS.

About this IDV

Written by GovTribe AI ·

The National Institutes of Health National Institute of Neurological Disorders and Stroke awarded an indefinite-delivery/indefinite-quantity multiple award contract to Battelle Memorial Institute for Manufacturing and Nonclinical Studies Support for the Development of Therapeutic Biotechnology Products for Neurological-related Disorders. The original solicitation sought to procure manufacturing and nonclinical services over five years to support the development of biotechnology products for neurological disorders, with an overall potential value of $149.2 million across all awardees.

Under the contract, Battelle has received several delivery orders to date for services including plasmid and vector manufacturing, GLP dose-escalation toxicology studies, liquid chromatography-mass spectrometry assay validation and testing, and development of enzyme-linked immunosorbent assays. These services will be performed at Battelle's Columbus, Ohio location through periods of performance ranging from 2023 to 2028. Delivery order values range from approximately $11,000 to over $10.9 million, with pricing on a cost-plus-fixed-fee basis except for one firm fixed price order.

The National Institute of Neurological Disorders and Stroke supports research to understand, treat and prevent disorders of the brain and nervous system. The contracted services are intended to support the development of biotechnology products for neurological disorders through nonclinical research services.

Task orders

Task order Ordering agency Obligated Awarded
Biologics IDIQ task order- non-GLP toxicity and toxicokinetic studies in rodents and non-rodents for a novel… 75N95025F00001 National Institute on Drug Abuse (NIH) $1,028,501
Kaler to - viral gene therapy for menkes disease 75N95024F00003 National Institute on Drug Abuse (NIH) $3,018,293
Non-GLP dose-range finding and GLP toxicity studies in minipigs and in vitro drug-drug interaction studies for a… 75N95024F00002 National Institute on Drug Abuse (NIH) $2,477,057
Validation of bioanalytical assays and IND- enabling GLP PD/PK toxicology studies in rats and dogs 75N95024F00001 National Institute on Drug Abuse (NIH) $1,553,595
Manufacturing of plasmid and vector and GLP dose-escalation toxicology studies in normal rats and normal nhps 75N95023F00003 National Institute on Drug Abuse (NIH) $10,643,547
Liquid chromatography with tandem mass spectrometry (hplc-MS-MS) assay validation and sample testing 75N95023F00002 National Institute on Drug Abuse (NIH) $494,704
Development of enzyme-linked immunosorbent assays (elisas) for ninds NIH blueprint neurotherapeutics (BPN) biologics… 75N95023F00001 National Institute on Drug Abuse (NIH) $531,194
Contract kickoff meeting and project management plan 75N95022F00001 National Institute on Drug Abuse (NIH) $11,476

Transactions

Action Obligated Date
Supplemental Agreement for work within scope P00002 $0
Supplemental Agreement for work within scope P00001 $0
Original award $0

Subawards

Subcontractor Amount Awarded
Charles River Laboratories, Inc. KALER TO - VIRAL GENE THERAPY FOR MENKES DISEASE NHP GLP Toxicology Study $302,076
Inotiv, Inc. KALER TO - VIRAL GENE THERAPY FOR MENKES DISEASE Rat GLP Dose-Ranging Toxicology Study $970,072
Inotiv, Inc. KALER TO - VIRAL GENE THERAPY FOR MENKES DISEASE Nonclinical Safety Genotoxicy $494,852
Attentive Science LLC BIOLOGICS IDIQ TASK ORDER- NON-GLP TOXICITY AND TOXICOKINETIC STUDIES IN RODENTS AND NON-RODENTS FOR A NOVEL, SUBCUTANEOUSLY-DOSED MODIFIED-HEPARIN DRUG non-GLP… $81,300
Subcontractor not on record MANUFACTURING OF PLASMID AND VECTOR AND GLP DOSE-ESCALATION TOXICOLOGY STUDIES IN NORMAL RATS AND NORMAL NHPS Ultra-Rare Gene-based Therapy Network $2,413,150
Kemp Proteins, LLC DEVELOPMENT OF ENZYME-LINKED IMMUNOSORBENT ASSAYS (ELISAS) FOR NINDS NIH BLUEPRINT NEUROTHERAPEUTICS (BPN) BIOLOGICS PROJECT Manufacture full-length recombinant… $47,965
QPS LLC NON-GLP DOSE-RANGE FINDING AND GLP TOXICITY STUDIES IN MINIPIGS AND IN VITRO DRUG-DRUG INTERACTION STUDIES FOR A SMALL PEPTIDE Non GLP Dose Range Finding and… $67,760
Inotiv, Inc. NON-GLP DOSE-RANGE FINDING AND GLP TOXICITY STUDIES IN MINIPIGS AND IN VITRO DRUG-DRUG INTERACTION STUDIES FOR A SMALL PEPTIDE study execution $186,873
Amplifybio LLC NON-GLP DOSE-RANGE FINDING AND GLP TOXICITY STUDIES IN MINIPIGS AND IN VITRO DRUG-DRUG INTERACTION STUDIES FOR A SMALL PEPTIDE Non-Clinical Studies $963,919
Andelyn Biosciences Inc. MANUFACTURING OF PLASMID AND VECTOR AND GLP DOSE-ESCALATION TOXICOLOGY STUDIES IN NORMAL RATS AND NORMAL NHPS Mfg of Plasmids/Vectors $4,638,934

Quick answers

Who was awarded contract 75N95022D00021?

75N95022D00021 was awarded to Battelle Memorial Institute by National Institute on Drug Abuse (National Institutes of Health) on September 28, 2022.

How much is contract 75N95022D00021 worth?

Orders under 75N95022D00021 have obligated $19,758,367. Their combined current value, with exercised options, is $19,849,505. Their combined potential value, with all options, is $39,145,050. 75N95022D00021's own ceiling is $149,200,000.

How many orders have been placed under contract 75N95022D00021?

8 orders have been placed under 75N95022D00021, the latest on September 29, 2025.

Which agency awarded contract 75N95022D00021?

National Institute on Drug Abuse (National Institutes of Health) awarded 75N95022D00021, with funding from National Institute of Neurological Disorders and Stroke (National Institutes of Health).

Who can order from contract 75N95022D00021?

75N95022D00021 is a multiple award indefinite delivery contract. Only the awarding agency can place orders on it.

Is contract 75N95022D00021 part of a contract vehicle?

Yes. 75N95022D00021 is part of Manufacturing and Nonclinical Studies Support for the Development of Therapeutic Biotechnology Products for Neurological-related Disorders.

Was contract 75N95022D00021 competed?

The extent of competition for 75N95022D00021 was full and open competition. The government received 3 offers.

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