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Automation of GMP manufacturing of HIV microbicide rings

Award Number: R44MH110161
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/01/2009
PERIOD OF PERFORMANCE END DATE: 06/30/2018

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Automation of GMP manufacturing of HIV microbicide rings - ¿ DESCRIPTION (provided by applicant): The broad long term goal of this work is to empower women in the developing world to protect themselves against HIV infection through the use of an HIV microbicide intravaginal ring. In Phase I and II of this project we developed the technology platform to deliver a broad range of antiretrovirals in our "Pod" IVRs. We confirmed the safety and pharmacokinetics of delivery in sheep and the ability of these rings to prevent infection in the macaque model. We also developed manufacturing methods to produce cGMP rings at a volume sufficient for carrying out clinical trials. In this Phase IIB program we propose to develop the capacity for cost effective manufacture of commercial lots of HIV microbicide intravaginal rings. Pod ring manufacture comprises 3 steps: blank ring manufacture; pod production; and assembly. We have successfully automated the first two steps to have the capacity for commercial lot production. The specific aim of this Phase IIB proposal is to develop and implement an automated assembly and packaging strategy. Our approach will comprise pilot and feasibility studies in the first year and transfer to cGMP in the second year. The successful completion of this aim will allow commercial lot manufacture which will allow cost-effective provision of microbicide rings to the developing 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: 2019 ( Subtotal = $0 )
2019	2016	AURITEC PHARMACEUTICALS, INC.	2285 E FOOTHILL BLVD	PASADENA	CA	91107	LOS ANGELES	USA	Mental Health Research Grants	000	6	11/15/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $1,145,062 )
2016	2016	AURITEC PHARMACEUTICALS LLC	15 BRAEBURN ROAD	HYDE PARK	MA	02136	SUFFOLK	USA	Mental Health Research Grants	000	5	10/27/2015	SUPPLEMENT FOR EXPANSION	$447,022
2016	2016	AURITEC PHARMACEUTICALS LLC	15 BRAEBURN ROAD	HYDE PARK	MA	02136	SUFFOLK	USA	Mental Health Research Grants	001	6	6/30/2016	NON-COMPETING CONTINUATION	$698,040
														Subtotal = $1,145,062

Issue Date FY: 2015 ( Subtotal = $337,439 )
2015	2015	AURITEC PHARMACEUTICALS LLC	15 BRAEBURN ROAD	HYDE PARK	MA	02136	SUFFOLK	USA	Mental Health Research Grants	000	5	9/24/2015	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$337,439
														Subtotal = $337,439

Grand Total All Awards = $1,482,501

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Automation of GMP manufacturing of HIV microbicide rings

Award Number: R44MH110161

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/01/2009

PERIOD OF PERFORMANCE END DATE: 06/30/2018

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