• Solicitation Status Awarded
• Date Awarded 2023-09-26
• Research Category Research & Development Services & Subcontracts
• Vendor Name Leidos Biomedical Research Inc.
• Solicitation Number S23-057
• NCI OA Contract Number 75N91019D00024 – NCI-FFRDC

Description

There has been a significant expansion of viral vectors for the development of therapeutics for rare diseases, leading to a demand for early-stage and proof-of-concept clinical studies. Such gene therapies require delivery of genetic material into cells via vial vectors. Adeno-associated virus (AAV) has become the predominant method of delivery into cells due to limited pathogenicity and efficient infection. Products using AAV have successfully finished clinical trials and reached commercialization approval with the FDA. Noting the successes of AAV as the delivery system for gene therapies, the National Center for Advancing Translation Science (NCATS) has identified limitations existing in the manufacturing phase mainly due to accessibility to trade secrets and proprietary processes. In collaboration with NCATS, Leidos Biomed seeks subcontract support for the development of manufacturing technologies that are unencumbered by commercial proprietary interests and firewalls for the non-commercial applications supporting these early stage proof of concept studies.

The objective is to develop an open-access process for the generation and manufacturing methods of high-quality AAV vectors. The base of this task is to manufacture at least two of the AAV serotypes broadly in current use. Each of the two AAV serotype will use a gene of interest (GOI) identified by NCATS to validate the lab scale process. The process shall be scalable and optimized for manufacturing of AAV gene vectors. The subcontractor shall also support the manufacturing of gene therapy vectors for research and clinical use for the government and rare disease community using the platform process. Upon completion of development and manufacturing processes, analytical method optimization, and cell line and plasmid optimization would be compiled into robust summaries and offered through a protected, fee-free portal. Once the subcontractor demonstrates that the process is robust at a 200 L scale, all the process protocols, serotype specific analytical methods shall be made freely available to gene therapy community at large. For commercial use, the royalty framework, if any, should be clearly defined for materials like helper plasmids, transfection reagents and Host cell line by the contractor, if they have licensed them from a third party. The eventual goal is to manufacture material in quantities sufficient to support preclinical and current Good Manufacturing Practices (cGMP) for clinical studies and deliver associated data packages to timely enable clinical trials.

Proposal Instructions

Offeror question or request for clarification are due no later than 1:00 PM ON APRIL 6, 2023. Offers are due no later than 1:00 PM ON MONDAY APRIL 24, 2023. For the full solicitation package, please contact Devan Wassum at devan.wassum@nih.gov.