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Development and Experimental Verification of Fundamental Models to Enable Implementation of Microwave-Assisted Freeze Drying

Award Number: U01FD007689
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: 08/31/2025

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Development and Experimental Verification of Fundamental Models to Enable Implementation of Microwave-Assisted Freeze Drying - Project Summary/Abstract Physical Sciences Inc. (PSI), in collaboration with the University of Connecticut (UConn), and with industry participation form Merck, proposes to develop and verify a fundamental model of Microwave- Assisted Freeze Drying (MAFD) to enable its implementation for pharmaceutical manufacturing. This effort will leverage primary drying models of traditional shelf-based freeze drying in vials developed and tested with support from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Our goal is to develop a heat and mass transfer model of the primary drying, or ice sublimation phase of MAFD freeze- drying, the most time consuming and critical phase. The model will predict the temperature of the product throughout primary drying and the drying time based on input parameters for the container system (e.g. vial, tray or dual chamber syringe), the product formulation (e.g. dielectric properties, resistance to drying, etc.), and the process conditions (e.g. microwave frequency, microwave power, chamber pressure). This program supports the advancement of regulatory science to facilitate the implementation of emerging manufacturing technology in the pharmaceutical sector. Microwave-assisted freeze drying (MAFD) is emerging as an alternative to traditional freeze drying as MAFD can significantly reduce processing costs and time compared to traditional freeze drying while maintaining product efficacy and stability. For example, studies have shown an approximately 80% reduction in cycle time using MAFD over traditional freeze drying. MAFD has more commonly been used in the food industry, and has not been applied to drying of pharmaceutical products at a large scale. This is partially due to a lack of knowledge of formulation response to microwave energy, and heat and mass transfer in MAFD processes to ensure efficient process design while maintaining product quality attributes. The successful completion of this program will result in a heat and mass transfer model of MAFD and a database of formulation microwave power absorption that can be used by industry to enable implementation of MAFD processes. Transitioning from traditional freeze drying to MAFD will result in reduced processing costs and cycle times and enable more agile manufacturing including on-demand and semi-continuous processes. This effort is particularly relevant during this current global pandemic. Administration of the current COVID-19 vaccines was limited by cold chain storage requirements. As COVID-19 vaccination programs transition from emergency response to routine administration, the economics of production and distribution will become more crucial. It is likely that future development of the COVID-19 vaccines will focus on freeze drying for product stabilization and distribution. Many common vaccines require freeze-drying, including those to prevent measles, yellow fever, Hib, BCG, H1N1, etc. Development of economical freeze-drying cycles will be critical for production of COVID-19 vaccines in manufacturing facilities around the world.


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 = -$6,420 )
2026	2023	PHYSICAL SCIENCES INC.	20 NEW ENGLAND BUSINESS CENTER DR	ANDOVER	MA	01810	ESSEX	USA	Food and Drug Administration Research	000	2	2/19/2026	NON-COMPETING CONTINUATION	-$6,420
														Subtotal = -$6,420

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	PHYSICAL SCIENCES INC.	20 NEW ENGLAND BUSINESS CENTER DR	ANDOVER	MA	01810	ESSEX	USA	Food and Drug Administration Research	000	2	8/22/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $999,842 )
2023	2023	PHYSICAL SCIENCES INC.	20 NEW ENGLAND BUSINESS CTR DR	ANDOVER	MA	01810	ESSEX	USA	Food and Drug Administration Research	000	2	9/5/2023	NON-COMPETING CONTINUATION	$999,842
														Subtotal = $999,842

Issue Date FY: 2022 ( Subtotal = $999,448 )
2022	2022	PHYSICAL SCIENCES INC.	20 NEW ENGLAND BUSINESS CTR DR	ANDOVER	MA	01810	ESSEX	USA	Food and Drug Administration Research	000	1	8/16/2022	NEW	$999,448
														Subtotal = $999,448

Grand Total All Awards = $1,992,870

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Development and Experimental Verification of Fundamental Models to Enable Implementation of Microwave-Assisted Freeze Drying

Award Number: U01FD007689

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: 08/31/2025

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