FDA awards $24.1M for 242 peptides, with GenScript USA Inc. securing the contract

Contract Overview

Contract Amount: $24,123 ($24.1K)

Contractor: Genscript USA Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2022-08-31

End Date: 2023-08-30

Contract Duration: 364 days

Daily Burn Rate: $66/day

Competition Type: COMPETED UNDER SAP

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: PROVIDE 242 PEPTIDES FOR FOOD AND DRUG ADMINISTRATION, (FDA) CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

Place of Performance

Location: SILVER SPRING, MONTGOMERY County, MARYLAND, 20993

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $24,122.98 to GENSCRIPT USA INC for work described as: PROVIDE 242 PEPTIDES FOR FOOD AND DRUG ADMINISTRATION, (FDA) CENTER FOR BIOLOGICS EVALUATION AND RESEARCH Key points: 1. Contract awarded for essential biological materials, supporting critical research and development. 2. The fixed-price nature of the award provides cost certainty for the agency. 3. A single award indicates potential for focused supplier relationship or specific capability requirements. 4. The contract duration of one year suggests a need for ongoing, but not necessarily long-term, supply. 5. The award falls under the Biological Product manufacturing category, highlighting specialized industry needs. 6. The use of a purchase order indicates a streamlined procurement process for goods.

Value Assessment

Rating: good

The contract value of $24.1 million for 242 peptides appears reasonable given the specialized nature of biological materials. Without specific per-peptide cost data or benchmarks for similar custom peptide synthesis contracts, a precise value-for-money assessment is challenging. However, the fixed-price structure suggests the agency has negotiated a set cost for the deliverables, mitigating risk of cost overruns. The award to a single entity may indicate a competitive process that identified a best-value offer or a sole-source situation if specific capabilities were required.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was competed under the Simplified Acquisition Procedures (SAP), which typically allows for full and open competition for procurements below a certain threshold. While the exact number of bidders is not specified, the 'COMPETED UNDER SAP' designation implies that multiple offers were solicited and considered. The competition level, even within SAP, should drive price discovery and ensure the government receives competitive pricing for the peptides.

Taxpayer Impact: The competitive nature of this award, even under SAP, is beneficial for taxpayers as it likely resulted in a more favorable price than a sole-source procurement. It ensures that public funds are used efficiently by leveraging market forces.

Public Impact

The primary beneficiary is the Food and Drug Administration (FDA), specifically the Center for Biologics Evaluation and Research (CBER). The contract delivers 242 distinct peptides, which are crucial components for biological research, drug development, and diagnostic testing. The geographic impact is primarily within the United States, supporting federal research initiatives. This contract supports the specialized workforce within the biotechnology and pharmaceutical sectors involved in peptide synthesis and analysis.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for supply chain disruption if the sole awardee faces production issues.
Reliance on a single vendor may limit flexibility in sourcing alternative or supplementary materials.
The fixed-price contract, while offering cost certainty, could lead to less incentive for the contractor to innovate or offer cost savings beyond the scope.

Positive Signals

The contract is awarded to a known entity (GenScript USA Inc.), suggesting a potentially established relationship and understanding of requirements.
The fixed-price contract provides budget predictability for the FDA.
The procurement process under SAP is generally efficient, allowing for timely acquisition of needed materials.

Sector Analysis

The biotechnology and pharmaceutical sector is characterized by high R&D investment and specialized manufacturing processes. Peptide synthesis is a critical component within this sector, serving as building blocks for therapeutics, diagnostics, and research tools. The market for custom peptides is competitive, with numerous companies offering synthesis services. This contract fits within the broader landscape of federal spending on life sciences research and development, supporting agencies like the FDA in their mission to ensure the safety and efficacy of medical products.

Small Business Impact

The data indicates this contract was not set aside for small businesses (ss: false, sb: false). As a competed contract under SAP, there may have been opportunities for small businesses to participate, but the award was not exclusively targeted towards them. The prime contractor, GenScript USA Inc., is a significant player in the biotech supply chain, and their role does not inherently preclude subcontracting opportunities, though specific subcontracting plans are not detailed here. The overall impact on the small business ecosystem would depend on whether smaller firms were involved as subcontractors.

Oversight & Accountability

Oversight for this contract would primarily reside with the contracting officers and program managers within the FDA's Center for Biologics Evaluation and Research. As a purchase order, it falls under the standard administrative and financial oversight mechanisms of the Department of Health and Human Services. Transparency is facilitated through contract databases like FPDS. While no specific Inspector General (IG) jurisdiction is mentioned, the HHS OIG has broad authority to investigate fraud, waste, and abuse within the department's programs and contracts.

Related Government Programs

National Institutes of Health (NIH) Research Grants
Centers for Disease Control and Prevention (CDC) Public Health Programs
Department of Defense (DoD) Medical Research
Biotechnology Research and Development Contracts

Risk Flags

Single Award Risk
Supply Chain Dependency
Potential for Price Escalation in Future Procurements

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $24,122.98 to GENSCRIPT USA INC. PROVIDE 242 PEPTIDES FOR FOOD AND DRUG ADMINISTRATION, (FDA) CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

Who is the contractor on this award?

The obligated recipient is GENSCRIPT USA INC.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Food and Drug Administration).

What is the total obligated amount?

The obligated amount is $24,122.98.

What is the period of performance?

Start: 2022-08-31. End: 2023-08-30.

What is the historical spending pattern for peptide procurement by the FDA?

Analyzing historical spending patterns for peptide procurement by the FDA requires access to detailed contract databases over multiple fiscal years. Without this specific data, it's difficult to provide a precise historical context. However, federal agencies like the FDA typically procure specialized biological materials like peptides on an as-needed basis to support research, development, and regulatory functions. Spending can fluctuate based on specific research initiatives, emerging scientific needs, and the availability of new technologies. Contracts for such items are often competed, with values varying significantly based on quantity, purity, complexity, and the specific supplier. Trends might show an increase in demand for custom peptides as biological research becomes more sophisticated and personalized medicine advances.

How does the per-unit cost of these peptides compare to market rates for similar custom synthesis?

Determining the precise per-unit cost benchmark for these 242 peptides is challenging without knowing the specific characteristics of each peptide (e.g., length, purity, modifications, scale of synthesis). Custom peptide synthesis costs can vary dramatically. Generally, longer peptides, higher purity requirements, and complex modifications (like phosphorylation or cyclization) significantly increase the price per milligram or gram. GenScript USA Inc. is a known provider in this market, and their pricing is generally considered competitive, but often falls within the mid-to-high range due to their comprehensive service offerings and quality controls. A thorough benchmark would involve comparing the negotiated price per unit against quotes from several other reputable custom peptide synthesis providers for identical or highly similar specifications.

What is GenScript USA Inc.'s track record with federal contracts, particularly with the FDA?

GenScript USA Inc. has a history of receiving federal contracts, including those from the FDA and other health-related agencies like the National Institutes of Health (NIH). Their track record generally indicates experience in providing a range of biological products and services, including custom peptide synthesis, gene synthesis, and protein expression. Reviewing their contract history would reveal the types of awards, their values, and performance outcomes, if publicly available. For this specific contract, the award suggests they met the FDA's requirements and were deemed a suitable supplier through a competitive process. Past performance is a key factor in federal procurement, and successful contract completion typically builds confidence for future awards.

What are the potential risks associated with relying on a single supplier for these critical peptides?

Relying on a single supplier, even in a competitive award scenario, introduces several potential risks. Firstly, there's the risk of supply chain disruption. If GenScript USA Inc. experiences unforeseen issues such as production problems, quality control failures, natural disasters affecting their facilities, or labor shortages, the FDA's research and development activities could be significantly delayed or halted. Secondly, a sole-supplier situation can reduce the agency's leverage in future negotiations; the contractor may have less incentive to offer competitive pricing or expedited service in subsequent procurements if alternatives are limited. Lastly, there's a potential risk related to innovation; the single supplier might not be as motivated to introduce novel synthesis methods or cost-saving technologies compared to a market with more active competition.

How does this contract align with the FDA's broader mission and strategic goals?

This contract directly aligns with the FDA's core mission of protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food, cosmetics, and products that emit radiation. Specifically, by procuring essential peptides for the Center for Biologics Evaluation and Research (CBER), the FDA is supporting the foundational scientific work necessary for evaluating and approving new biological therapies, vaccines, and diagnostics. These peptides likely serve as critical reagents or components in research aimed at understanding diseases, developing countermeasures, and ensuring the quality of biological products used by the public. Therefore, this procurement is instrumental in advancing the FDA's regulatory science and public health protection mandate.

Industry Classification

NAICS: Manufacturing › Pharmaceutical and Medicine Manufacturing › Biological Product (except Diagnostic) Manufacturing

Product/Service Code: INSTRUMENTS AND LABORATORY EQPT

Competition & Pricing

Extent Competed: COMPETED UNDER SAP

Solicitation Procedures: SIMPLIFIED ACQUISITION

Solicitation ID: FDA-1257348

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 860 CENTENNIAL AVE, PISCATAWAY, NJ, 08854

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $24,123

Exercised Options: $24,123

Current Obligation: $24,123

Actual Outlays: $24,123

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Timeline