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Advancing continuous biomanufacturing of monoclonal antibodies using an experimentally validated modeling platform

Award Number: U01FD007695
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2022
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Advancing continuous biomanufacturing of monoclonal antibodies using an experimentally validated modeling platform - Project Summary Due to increased demand for biologics, there is an ongoing need to scientifically and commercially advance manufacturing in both upstream cell culture and downstream purification steps. Our goal is to provide an experimental infrastructure complemented by a computational framework to investigate the continuous manufacturing of monoclonal antibodies (mAbs). The modeling approach will be based and validated using specific experimental evidence to enhance our process understanding and improve model performance and utilization during the design phase. The proposed innovations stem from the following objectives that will be delivered as the outcome of this project, namely, 1) To develop a multiscale model for perfusion bioreactor capturing the effects of operating parameters and cell line characteristics on critical quality attributes (CQAs) validated by experimental results; 2) To develop methods for optimizing continuous chromatographic operations, including primary capture and polishing steps, under a range of process conditions for optimal clearance of process- and product-related impurities; and 3) To develop predictive models that will enable determination of optimal operating conditions with direct coupling of upstream and downstream units accounting for product quality attributes. To enable process control, which is the ultimate target of advanced manufacturing, we will explore the design space and identify the relationships between critical process parameters (CPPs), critical material attributes (CMAs), and targeted CQAs. We will develop predictive models for all the important unit operations, validated by experiments, that can be used to determine the design space along with statistical analysis of experimental data to identify all critical parameters/attributes. The validated models will then be used as a virtual tool to perform risk assessment for in-plant downstream operations such as scale-up/start-up/shutdown and compare process operating scenarios. In terms of combining the developed strategies, we envision the integration with a continuous upstream facility to achieve a fully automated continuous biomanufacturing line exploring and optimizing the process interactions. This proof-of-concept line will be used to clearly quantify risk and performance-based metrics.


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: 2026 ( Subtotal = $0 )
2026	2025	UNIVERSITY OF DELAWARE	550 S COLLEGE AVE	NEWARK	DE	19713	NEW CASTLE	USA	Food and Drug Administration Research	000	4	12/15/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $879,670 )
2025	2025	UNIVERSITY OF DELAWARE	550 S COLLEGE AVE	NEWARK	DE	19713	NEW CASTLE	USA	Food and Drug Administration Research	000	4	9/22/2025	NON-COMPETING CONTINUATION	$879,670
														Subtotal = $879,670

Issue Date FY: 2024 ( Subtotal = $882,827 )
2024	2024	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Food and Drug Administration Research	000	3	9/12/2024	NON-COMPETING CONTINUATION	$882,827
														Subtotal = $882,827

Issue Date FY: 2023 ( Subtotal = $958,121 )
2023	2023	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Food and Drug Administration Research	000	2	8/14/2023	NON-COMPETING CONTINUATION	$958,121
														Subtotal = $958,121

Issue Date FY: 2022 ( Subtotal = $929,598 )
2022	2022	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Food and Drug Administration Research	000	1	8/10/2022	NEW	$929,598
2022	2022	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Food and Drug Administration Research	003	1	9/23/2022	SUPPLEMENT FOR EXPANSION	$529,598
2022	2022	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Food and Drug Administration Research	002	1	9/23/2022	NEW	-$529,598
2022	2022	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Food and Drug Administration Research	001	1	8/12/2022	NEW	$0
														Subtotal = $929,598

Grand Total All Awards = $3,650,216

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Advancing continuous biomanufacturing of monoclonal antibodies using an experimentally validated modeling platform

Award Number: U01FD007695

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2022

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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