Acquisition of Services for cGMP Testing of PEN-866 Drug Conjugate Tender, USA - 122712982

Procurement Summary

Country : USA

Summary : Acquisition of Services for cGMP Testing of PEN-866 Drug Conjugate

Deadline : 18 Jul 2025

Other Information

Notice Type : Tender

TOT Ref.No.: 122712982

Document Ref. No. : 75N91025Q00045

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB) plans to procure, on a sole source basis, for the generation of a new Certificate of Analysis (CoA) for the drug conjugate PEN-866 from:

PPD Development LP (PPD) 929 N Front St Wilmington, NC 28401

The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1 (b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541380 (Testing Laboratories and Services) and the business size standard is $19.0 Million.

PEN-866 is a HSP90 inhibitor-drug-conjugate which effectively regresses tumors and improves survival in multiple models of pediatric sarcoma. The National Cancer Institute (NCI) currently holds the existing drug supply, and the open clinical trial is being conducted without an industry partner with NCI as the sponsor. To stay in compliance with federal regulations, samples of the drug production batch used in the clinical trial must be regularly tested for their stability for the duration of the trial.

NCI originally obtained its supply of PEN-866 from Tarveda Therapeutics which is no longer in business. After production of the initial PEN-866 batch, PPD then developed and validated protocols for stability and purity testing for PEN-866 during the initial phases of clinical trials. As such, PPD is the only vendor with established and validated protocols for testing PEN-866. For that reason, PPD is the only vendor who can meet the Government-s need for ongoing stability and purity testing of PEN-866 without significant delays or duplicated cost to the Government. For those reasons PPD is the only vendor who ...
Active Contract Opportunity
Notice ID : 75N91025Q00045
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : NATIONAL INSTITUTES OF HEALTH
Office: NIH NCI
General Information
Contract Opportunity Type: Presolicitation (Original)
Original Published Date: Jul 14, 2025 07:17 am EDT
Original Response Date: Jul 18, 2025 10:00 am EDT
Inactive Policy: Manual
Original Inactive Date: Jul 18, 2025
Initiative: None

Classification
Original Set Aside:
Product Service Code: Q301 - REFERENCE LABORATORY TESTING
NAICS Code: 541380 - Testing Laboratories and Services

Place of Performance: USA

Documents

 Tender Notice

NCI_SOW_PEN-866_Testing.pdf