E. coli prebank testing, master cell banking and working cell bank

Added: Nov 08, 2017 3:27 pm This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Charles River Laboratory, Wilmington, MA to procure the service of cell production and master and working cell banking.

The manufacturing and testing of these cells will be used in support of ongoing research at the Laboratory of Malaria Immunology and Vaccinology (LMIV) to research, pursue, produce and clinical trial malaria vaccines. Place of Performance is Rockville, MD 20852.

Charles River Laboratories has produced the master and working cell banks for LMIV for the production of cGMP grade malaria vaccines at the NCI's BDP manufacturing plant. CRL has undergone an audit and were found to be in full compliance with cGMP and FDA standards.
CRL has separate facilities for microbial and yeast cell banking to reduce the risk of contamination. We require that the manufacturing and testing of the cGMP cell banks to be performed to the standards as required by the FDA for inclusion in investigational new drug (IND) applications which is the review document we must submit to the FDA prior to human testing in a Clinical trial.

The statutory authority for this sole source requirement is 41 U.S.C. 253 (c) (1) as implemented by FAR 6.302-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-RML-D-1878336) to Skye Duffner at skye.duffner@nih.gov by 5:00 pm eastern standard time, Friday, November 17, 2017. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.