NIH Reporter #1ZICBC012049-05

QC and Release Testing Services for Clinical Gene Therapy Products

The National Cancer Institute (NCI), Division of Basic Sciences, is seeking specialized quality control and release testing services for clinical gene therapy products. - Government Buyer: - National Cancer Institute (NCI), Division of Basic Sciences - Services Requested: - Quality control (QC) and release testing for vector and cell products used in clinical gene therapy - Assays required include: - Vector titer measurement - T-cell receptor (TCR) specificity testing - Detection of residual contaminants - Sterility testing - Services support the development of personalized therapies and require complex cell-based and molecular assays - OEMs and Vendors: - No specific OEMs or vendors are named in the solicitation - Unique/Notable Requirements: - Emphasis on advanced, specialized assays for gene therapy products - Supports clinical research and personalized medicine initiatives - Estimated Contract Value: - $1,154,517 (for fiscal year 2025)

Description

This project involves quality control and release testing of vector and cell products used in clinical gene therapy. The scope includes assays for vector titer, TCR specificity, residual contaminants, and sterility. The work supports personalized therapies and involves complex cell-based and molecular assays. The funding is provided by the National Cancer Institute for fiscal year 2025.

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