A -- PRODUCTION OF ADENOVIRAL VECTORS

Notice Date

July 11, 2001

Contracting Office

NCI Frederick Cancer Research and Development Center (NCI-FCRDC), P.O. Box B, Frederick, Maryland 21702-1201

ZIP Code

21702-1201

Response Due

August 13, 2001

Point of Contact

Patricia L. Getzandanner, Sr. Contract Specialist, 301-846-1721, Contracting Officer -- Dennis J. Dougherty, 301-846-1087

E-Mail Address

Patricia L. Getzandanner, Sr. Contract Specialist (pgetzandanner@mail.ncifcrf.gov)

Description

Introduction: Manufacturing -- Potential Sources Sought. The Vaccine Research Center (VRC), a newly created center within the National Institute of Allergy and Infectious Disease (NIAID), National Institutes of Health (NIH) is seeking contractors for the production of adenoviral vectors for candidate vaccine products. Several HIV-1 vaccine candidates based on live recombinant vectors encoding HIV-1 proteins have been tested in humans. These have been shown to be safe and immunogenic, but induce only weak to moderate HIV-1 specific immune responses. Recombinant adenoviral vectors have been widely investigated in recent years as a gene delivery system for gene therapy and vaccination. The ability of these vectors to mediate efficient transfer and expression of candidate therapeutic or vaccine genes in a variety of cell types, including post-mitotic cells, is considered an advantage over other gene transfer vectors. Recombinant adevoviral vectors are highly immunogenic in small animals and monkeys and are an attractive platform for gene-based immunization. It is the purpose of this Sources Sought notice to identiy contractors who can perform the production, characterization and testing of adenoviral vectors based on modified HIV-1 genes developed at the VRC. The VRC is seeking contractors who have current production systems that are constructed to eliminate the possibility of generating Replication Competent Adenovirses (RCA). Contractors should have expertise in a broad range of adenoviral vector production techniques, and be able to provide thorough characterization and tracibility of cell lines and vector so that they meet FDA requirements for use in human clinical trials. We are seeking contractors who can provide a broad range of services in three specific areas: packaging cell lines, adenoviral vector construction, and cGMP production and testing. Contractors may respond to one or all areas; however, the ability to perform a range of modality certifications will be preferred. Packaging Cell Lines -- Provide suitable packaging cell line for the production replication deficient adenoviral vectors. There should be no possibility of recombination between the packaging cell line and the adenoviral vector to generate replication competent adenovirus (RCA). Cell line must be characterized according all appropriate FDA and ICH guidelines for the use of cell substrates in the production of biological products for use in clinical trials. These cell lines must also be suitable for final product licensure to be used in the manufacture of vaccine product for distribution. Adenoviral Vectors -- A suitable adenoviral vector to be used with the proposed packaging cell line. This vector will be used to insert HIV-1 modified genes for the production of candidate products. cGMP production of clinical products -- Contractor will manufacture clinical lots of adenoviral vectors containing modified HIV-1 genes in accordance to FDA cGMP guidelines for clinical trials. Organizations interested in participating are requested to contact Patricia Getzandanner, Sr. Contract Specialist, #301-846-1721, or e-mail at pgetzandanner@mail.ncifcrf.gov

Record

Loren Data Corp. 20010713/ASOL009.HTM (W-192 SN50R4L7)