Tender Details

Country: USA
Summary: Acquisition of Services for cGMP Testing of PEN-866 Drug Conjugate
UST Ref No: 122712982
Deadline: 18 Jul 2025
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: Refer Document
Notice Type: Tender
Document Ref. No.: 75N91025Q00045
Purchaser's Detail:
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Description:
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 ...
Documents:

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

The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | NATIONAL INSTITUTES OF HEALTH, a Government sector organization in USA, has announced a new tender for Acquisition of Services for cGMP Testing of PEN-866 Drug Conjugate. This tender is published on USARFP under UST Ref No: 122712982 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-07-18.

The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.