Contact Points
PHILADELPHIA, PA 19103-6606
The NINDS Neuromuscular and Neurogenetic Disorders of Childhood Section (NNDCS) requires immunological testing of human biospecimens collected under NINDS-sponsored gene therapy protocol 15-N-0073. The vendor must have expertise in conducting neutralizing antibody and ELISpot assays following administration of gene therapy products to human subjects.
This is a new requirement in order to support critical safety-related immunological testing on NINDS clinical trial participants. Specifically, this contract will support testing of participants enrolled in protocol 15-N-0073: “A Phase I Study of Intrathecal Administration of scAAV9/JeT-GAN for the Treatment of Giant Axonal Neuropathy”. Human biospecimens will be submitted to the vendor for analysis, processed by the vendor, and results returned to the NINDS via NIH BOX in the form of cumulative data extracts and PDF (source) signed testing reports.
• Service 1 (PBMC isolation): Isolation of peripheral blood mononuclear cells (PBMCs) is essential for accurate analysis of a T-cell-mediated immune response against the gene therapy product via ELISpot assay.
• Product 1 (NAb assay testing): Analysis of neutralizing antibodies against the capsid (AAV9) of the investigational product is essential for informing whether an immune response against the gene therapy product has occurred, which could impact safety/efficacy.
• Product 2 (EISpot assay testing): Analysis of T-cell-mediated immune response via this specific assay is essential for informing whether an immune response against the gene therapy product has occurred, which could impact safety/efficacy.
Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.
All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.
All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.