The Biomedical Advanced Research and Development Authority (BARDA) has issued a Request for Project Proposals (RPP) for “Manufacturing Optimization for Filovirus Monoclonal Antibodies.” The RPP was released on June 24, 2024, with proposals due by July 22, 2024. This initiative aims to enhance the manufacturing development of monoclonal antibody (mAb) cocktails targeting filoviruses like Ebola and Marburg viruses.
Purpose of the RPP
BARDA’s mission is to develop vaccines, drugs, therapies, and diagnostic tools for public health emergencies, including chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases. The 2006 Material Threat Determination by the Department of Homeland Security (DHS) highlighted Ebola and Marburg viruses as significant threats to national health security. In response, BARDA aims to bolster its countermeasure capabilities with therapeutics targeting filovirus diseases caused by Ebola virus (EBOV), Marburg virus (MARV), and Sudan virus (SUDV).
Currently, the only FDA-approved therapeutics for Ebola Virus Disease (EVD) are Inmazeb and Ebanga, both monoclonal antibodies. There are no approved treatments for SUDV or MARV infections. BARDA seeks to advance the manufacturing development of a mAb cocktail comprising two antibodies, 1C3 and 1C11, developed by Emory Vaccine Center. These antibodies, isolated from filovirus survivors, target the glycoprotein (GP) trimer and neutralize diverse ebolaviruses.
Project Scope and Objectives
The selected contract development and manufacturing organizations (CDMOs) will focus on cell line generation and initial manufacturing process development for the mAb cocktail at a scale of 5 liters or more. The project is divided into a base period and two option periods:
- Base Period: Generation of stable 1C3 and 1C11-expressing cell lines and initial process development. This includes establishing a clonal cell line, cell culture process in scalable bioreactors, and purification of drug substances.
- Option Period 1: Expression and manufacturing optimization at a pilot scale. This involves creating a Master Cell Bank, optimizing upstream and downstream processes, and formulation development for the drug substances.
- Option Period 2: Technology transfer to another CDMO, if necessary, based on agreements with the intellectual property holder.
Proposal Requirements and Evaluation
Proposals must include a technical proposal and a cost proposal, submitted via the BioMaP-Consortium’s online system. The technical proposal should detail the approach to cell line generation, process development, and manufacturing optimization. Proposals will be evaluated based on technical approach, relevant corporate experience and capabilities, program management approach, and cost/price.
The evaluation process includes preliminary compliance screening, a comprehensive review by a government sponsor team, and potential use of subject matter experts (SMEs) and contractor consultants. Proposals may be recommended for award, placed in a “Basket” for future consideration, or rejected based on their evaluation.
Key Dates
- June 24, 2024: RPP release date
- July 8, 2024: Deadline for submitting questions
- July 12, 2024: Live Q&A session with government responses
- July 22, 2024, 1 PM ET: Proposal submission deadline
This RPP reflects BARDA’s commitment to enhancing the nation’s preparedness against filovirus outbreaks by developing cost-effective therapeutic countermeasures through innovative manufacturing processes.
If your company has considered applying for BARDA funding, your federal funding journey starts here.
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