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Low-temperataure plasma decontamination of pharmaceutical manufacturing fill/finish operations

Award Number: R44TR001847
ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary/Abstract The goal of the proposed SBIR program is to develop a pharmaceutical manufacturing decontamination system using the innovative PSI atmospheric pressure microwave microplasma technology. Commercialization of this technology is targeted to replace the use of vapor phase hydrogen peroxide (VPHP) in parenteral drug manufacturing facilities, including barrier isolator sterilization systems and lyophilizers. The replacement of VPHP in decontaminating aseptic pharmaceutical manufacturing facilities will eliminate the significant shortcomings associated with residual VPHP following sterilization, including its deleterious effects on biotechnology drug therapies and the challenge associated with reliably monitoring part per billion (ppb) levels of VPHP in manufacturing environments. This development targets the USFDA process analytical technology (PAT) initiative for building quality into pharmaceutical products, the industry Quality by Design (QbD) initiative, and the national goal to modernize pharmaceutical manufacturing. The proposed R&D supports increasing the availability of critical drug products like vaccines and biotechnology drugs, the fastest growing segment of the industry. Improved manufacturing technologies will ultimately reduce the costs of prescription drug products.


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: 2022 ( Subtotal = -$1,796 )
2022	2019	PHYSICAL SCIENCES INC.	20 NEW ENGLAND BUSINESS CTR DR	ANDOVER	MA	01810	ESSEX	USA	National Center for Advancing Translational Sciences	000	3	4/26/2022	NON-COMPETING CONTINUATION	-$1,796
														Subtotal = -$1,796

Issue Date FY: 2019 ( Subtotal = $595,598 )
2019	2019	PHYSICAL SCIENCES INC.	20 NEW ENGLAND BUSINESS CTR DR	ANDOVER	MA	01810	ESSEX	USA	National Center for Advancing Translational Sciences	000	3	11/19/2018	NON-COMPETING CONTINUATION	$595,598
														Subtotal = $595,598

Issue Date FY: 2018 ( Subtotal = $583,124 )
2018	2018	PHYSICAL SCIENCES INC.	20 NEW ENGLAND BUSINESS CTR DR	ANDOVER	MA	01810	ESSEX	USA	National Center for Advancing Translational Sciences	000	2	11/28/2017	COMPETING CONTINUATION	$583,124
														Subtotal = $583,124

Grand Total All Awards = $1,176,926

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Low-temperataure plasma decontamination of pharmaceutical manufacturing fill/finish operations

Award Number: R44TR001847

ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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