Notice of RFI & Sources Sought: BARDA Manufacturing Optimization for Filovirus Human Monoclonal Antibodies

Objective The objective of this Request for Information (RFI) is for BARDA program officials to better refine the requirements for manufacturing optimization for Filovirus Human Monoclonal Antibodies. BARDA is considering using BARDA’s BioMaP-Consortium vehicle (BioMaP) for this project.

The information requested from this RFI will serve as continued market research in support of a potential program under BARDA’s BioMaP-Consortium wherein BARDA would partner with organizations to work towards advancing biomanufacturing technologies. None of the information in this RFI is intended to suggest a particular approach or contract solution. 2.0 Project Scope This initiative will support the advanced manufacturing development of a monoclonal antibody (mAb) cocktail.

A primary aim of this initiative is to identify a high yield, low-cost manufacturing process for the target mAbs that does not impact potency. The sequence information for the mAbs will be provided to Offerors after award, dependent upon execution of a Material Transfer Agreement (MTA) with the IP holder. The base period will focus on producing high yield cell lines that will support a scalable manufacturing process while maintaining product potency.

Multiple offerors are anticipated to be awarded the base period work, and products resulting from that work will then be sent to a CRO of BARDA’s choosing for potency assessment. After assessment, the government will evaluate the products generated in the Base period, using potency and cell line yield as the primary evaluation criteria. The government may then award an option period to select CDMOs (no more than two) for manufacturing optimization.

The option period may support optimization of upstream and downstream processes for drug substance production, prioritizing cost of goods and manufacturing as well as supporting proof of concept for manufacturability at a pilot scale (200-2000L); an additional option period may support technology transfer of the manufacturing process to another entity. Final deliverables will include manufacturing reports and a tech transfer report.

3.0 Sources Sought BARDA is interested in advancing manufacturing development for an already identified monoclonal antibody (mAb) cocktail composed of two mAbs. Work will be focused on the development of this antibody cocktail at a CDMO. BARDA anticipates project awards will be made to multiple Contract Development Manufacturing Organization’s (CDMOs) with the best solution and capability to manufacture the two antibodies. For futher details and a copy of the draft SOO, please see the attached documents. Thank you for your interest in this requirement!