Acquisition of Services for cGMP Testing of PEN-866 Drug Conjugate
ID: 75N91025Q00045Type: Presolicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNIH NCIBethesda, MD, 20892, USA

NAICS

Testing Laboratories and Services (541380)

PSC

MEDICAL- LABORATORY TESTING (Q301)

Original Source

https://sam.gov/opp/904eaefa46034469973d59145fca9884/view
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to procure services for the generation of a new Certificate of Analysis (CoA) for the drug conjugate PEN-866, which is critical for ongoing clinical trials involving pediatric and young adult cancer patients. The selected contractor will be responsible for conducting comprehensive testing and analysis under strict Current Good Manufacturing Practice (cGMP) regulations, ensuring the drug's stability and compliance throughout the trial period. PEN-866 is an important HSP90 inhibitor-drug-conjugate that has shown promise in tumor regression and survival improvement in various pediatric sarcoma models. Interested parties must submit their capability statements or proposals to Contracting Officer John Russell at John.Russell3@nih.gov by 10:00 A.M. EST on July 18, 2025, referencing notice number 75N91025Q00045. This acquisition will be processed as a sole source contract with PPD Development LP, the only vendor with established testing protocols for PEN-866.

    Point(s) of Contact
    John Russell, Contracting Officer
    John.Russell3@nih.gov
    Files
    Title
    Posted
    NCI_SOW_PEN-866_Testing.pdf
    The National Institutes of Health's Pediatric Oncology Branch seeks to acquire services for generating a new Certificate of Analysis (CoA) for the drug conjugate PEN-866, which targets tumor protein HSP90 for cancer treatment. Due to delays from the pandemic affecting the previous CoA, a new one is required for clinical trials involving pediatric and young adult patients. The contractor will carry out tasks under strict Current Good Manufacturing Practice (cGMP) regulations including method verification, drug analysis with comprehensive testing parameters, and long-term storage. The work is segmented into specific tasks such as familiarization with established methods, conducting detailed analyses on the drug's compliance, and preparing the CoA, all within specified timeframes. Additionally, options for ongoing testing and storage are outlined for up to four years post-initial certification. All deliverables must meet accessibility standards, ensuring compliance and equal access to information. Overall, the file outlines the framework for safe testing and analysis of PEN-866, essential for its further development in treating cancer in young patients.
    Lifecycle
    Title
    Type
    Acquisition of Services for cGMP Testing of PEN-866 Drug Conjugate
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    Presolicitation
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