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A modular platform for rapid VLP vaccine development and manufacturing for SARS-CoV-2 pandemic response

Award Number: R01FD007458
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2021
PERIOD OF PERFORMANCE END DATE: 02/28/2025

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A modular platform for rapid VLP vaccine development and manufacturing for SARS-CoV-2 pandemic response - Project Summary: A modular platform for rapid VLP vaccine development and manufacturing for SARS-CoV-2 pandemic response This proposal aims to design, develop, and manufacture a virus-like particle (VLP) vaccine for SARS-CoV-2, and the techniques developed throughout the work can be applied to accelerate the vaccine pipeline in response to future pandemics. We will generate a VLP expression system in a HEK 293 host that efficiently creates a consistent VLP product. This production platform was designed such that the Spike protein characteristic of SARS-CoV-2 can be easily modified, allowing the vaccine to be modified in response to critical viral mutations. The resulting VLP production system will be scaled up and used for advanced process development. The VLPs will be generated in perfusion mode, resulting in a more productive platform with a high product yield. Successful implementation of perfusion processing for a VLP vaccine will enable other VLP based products to be more rapidly manufactured using a smaller facility footprint, enabling rapid manufacturing to meet the global demand. Advanced process analytical technology (PAT) will be applied to fully characterize the process and product, establishing a baseline Critical Quality Attribute (CQA) profile to ensure a consistently safe and effective product. Data collected during process development will be used to generate advanced processing models and robust control strategies for optimal production of the VLP vaccine. This highly collaborative effort will demonstrate a rapid, streamlined VLP vaccine development and manufacturing process that can reduce the time to vaccine rollout as new coronaviruses, coronavirus strains, and other viral pathogens emerge. Not only will the work proposed here generate a vaccine candidate for SARS-CoV-2, but the methodology described herein will generate a platform process for response to future pandemics or potential viral mutations.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2023	MASSACHUSETTS INSTITUTE OF TECHNOLOGY	77 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Food and Drug Administration Research	000	3	5/14/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	MASSACHUSETTS INSTITUTE OF TECHNOLOGY	77 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Food and Drug Administration Research	000	3	7/19/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $500,000 )
2023	2023	MASSACHUSETTS INSTITUTE OF TECHNOLOGY	77 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Food and Drug Administration Research	001	3	9/8/2023	NON-COMPETING CONTINUATION	$500,000
2023	2021	MASSACHUSETTS INSTITUTE OF TECHNOLOGY	77 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Food and Drug Administration Research	000	1	5/8/2023	NEW	$0
														Subtotal = $500,000

Issue Date FY: 2022 ( Subtotal = $500,000 )
2022	2022	MASSACHUSETTS INSTITUTE OF TECHNOLOGY	77 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Food and Drug Administration Research	000	2	9/1/2022	NON-COMPETING CONTINUATION	$500,000
														Subtotal = $500,000

Issue Date FY: 2021 ( Subtotal = $500,000 )
2021	2021	MASSACHUSETTS INSTITUTE OF TECHNOLOGY	77 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Food and Drug Administration Research	000	1	9/21/2021	NEW	$500,000
														Subtotal = $500,000

Grand Total All Awards = $1,500,000

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A modular platform for rapid VLP vaccine development and manufacturing for SARS-CoV-2 pandemic response

Award Number: R01FD007458

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2021

PERIOD OF PERFORMANCE END DATE: 02/28/2025

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