Inactive

PRE-SOLICITATION NOTICE **NOTICE OF INTENT NOI-NIAID-23-2183331 NAICS – 541380, Testing Services This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectiou... PRE-SOLICITATION NOTICE **NOTICE OF INTENT NOI-NIAID-23-2183331 NAICS – 541380, Testing Services 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 Laboratories, Inc of Wilmingon, MA to procure the preparation of Pichia Pfs230 master cell bank using GMP standards with required post bank testing for studies and vaccine development by the Laboratory of Malaria Immunology and Vaccinology (LMIV). LMIV Vaccine Development Unit develops and performs clinical evaluation of prototype malaria vaccines. Each candidate vaccine has to undergo a rigorous development process that requires the input of many highly skilled scientists with specific areas of expertise. These include creation of expression systems, fermentation optimization, scale-up of purification technology, clinical good manufacturing practices (cGMP) production, formulation, quality control, preclinical testing, and clinical trials. The Laboratory of Malaria Immunology and Vaccinology has approval to work with the Serum Institute of India for cGMP production and manufacture of our Pfs230 malaria vaccines for human use. The scope of the project is to develop a new Master cell bank that will be used for the fermentation production of cGMP grade Pfs230 for further processing into the developed malaria vaccine candidate. For that to happen we first require the manufacture of a Master Cell Bank using the clones of our choosing. For this project we require the cGMP manufacturing of a malaria vaccine target protein (called Pfs230) which is a critical component to our final vaccine candidate product. This work must be performed under cGMP regulations to be suitable for human use. LMIV has used Charles River Laboratories in the past for the manufacturing of cGMP cell banks that later went on to be used in human clinical trials. To meet the requirements of the FDA this testing must be performed by the vendor that has initially begun the work with on this project. NIH requires 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 Phase 1 Clinical trial. Once complete the some of the cell bank will be shared with Serum Institute of India for cGMP manufacturing and conjugation. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 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-NIAID-23-2183331) to Dana Monroe at dana.monroe@nih.gov, by 5:00pm ET, Monday, August 7, 2023. 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.