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Development of a Manufacturing Process for a Novel TB Vaccine

Award Number: R01AI098911
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/20/2012
PERIOD OF PERFORMANCE END DATE: 06/30/2018

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Development of a Manufacturing Process for a Novel TB Vaccine - DESCRIPTION (provided by applicant): Tuberculosis (TB) is a significant global health concern and is the second leading cause of death from infectious disease worldwide. Approximately two million deaths are attributed to TB annually. The TB epidemic has continued despite widespread use of the only available licensed TB vaccine, Bacille Calmette-Guerin (BCG), under the World Health Organization (WHO) expanded program on immunization (EPI). Although vaccination with BCG has been successful in preventing certain forms of TB infection in children, BCG has limited efficacy against pulmonary TB infection. Adding to the urgent need for improved TB management, the emergence of TB bacterial strains that are resistant to many of the available TB therapies increases the importance of developing new preventative agents. Mycobacterium tuberculosis, the bacteria that cause TB disease is a NIAID priority pathogen. Emergent BioSolutions Inc., is a biopharmaceutical company headquartered in Rockville, MD with laboratories and manufacturing facilities in the United States and Europe, collectively referred to as "Emergent" throughout this application. Emergent has formed a joint venture with the University of Oxford to form the Oxford-Emergent Tuberculosis Consortium Limited. (OETC) to rapidly advance the MVA85A tuberculosis vaccine. MVA85A is the world's most clinically advanced next generation vaccine candidate for the prevention of TB and is currently undergoing efficacy testing in a clinical efficacy study in South African infants. The vaccine has been shown to be safe, well tolerated and immunogenic in volunteers evaluated to date. Although MVA85A is clinically advanced, the use of Chicken Embryo Fibroblasts (CEFs) for production of MVA85A is inadequate to meet global demand for MVA85A. We have identified an avian cell line suitable for large-scale commercial manufacture at a reduced cost and are currently developing a manufacturing process for MVA85A. This project will focus on optimizing and characterizing this manufacturing process. Specific Aim 1, process optimization, will improve viral titer and purification yield to increase capacity and lower the cost of goods. Specific Aim 2, process characterization, will define the commercial manufacturing process based on knowledge gained through development and scale-up activities Specific Aim 3, Process Validation and Production of 200L Consistency Lots, will demonstrate that the process is capable of reproducible commercial manufacture and will meet the manufacturing requirements for initial licensure. Specific Aim 4, Process Scale up (200L to 2000L), will increase the process scale from 200L to 2000L to meet global demand for the vaccine. Specific Aim 5, Process Validation and Production of 2000L Consistency Lots, will provide assurance that the commercial manufacturing process performs as expected. In total, these studies will produce a commercial scale manufacturing process that will support the licensure of MVA85A. If licensed, MVA85A would be the first TB vaccine approved for use in over 90 years.


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 = $0 )
2022	2016	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.	300 PROFESSIONAL DR	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	5	10/1/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = -$1,170,282 )
2019	2016	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.	300 PROFESSIONAL DR	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	005	5	6/18/2019	EXTENSION WITH OR WITHOUT FUNDS	$27,455
2019	2016	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.	300 PROFESSIONAL DR	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	004	5	6/6/2019	EXTENSION WITH OR WITHOUT FUNDS	-$27,455
2019	2016	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.	300 PROFESSIONAL DR	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	002	5	2/12/2019	EXTENSION WITH OR WITHOUT FUNDS	-$1,197,737
2019	2016	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.	300 PROFESSIONAL DR	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	5	1/7/2019	EXTENSION WITH OR WITHOUT FUNDS	$27,455
2019	2015	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.	300 PROFESSIONAL DR	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	4	1/7/2019	NON-COMPETING CONTINUATION	-$27,455
2019	2015	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.	300 PROFESSIONAL DR	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	003	4	6/6/2019	NON-COMPETING CONTINUATION	$27,455
														Subtotal = -$1,170,282

Issue Date FY: 2016 ( Subtotal = $1,553,871 )
2016	2016	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	5	7/14/2016	EXTENSION WITH OR WITHOUT FUNDS	$1,553,871
														Subtotal = $1,553,871

Issue Date FY: 2015 ( Subtotal = $1,553,871 )
2015	2015	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	4	6/29/2015	NON-COMPETING CONTINUATION	$1,553,871
														Subtotal = $1,553,871

Issue Date FY: 2014 ( Subtotal = $1,553,871 )
2014	2014	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	3	6/13/2014	NON-COMPETING CONTINUATION	$1,553,871
														Subtotal = $1,553,871

Issue Date FY: 2013 ( Subtotal = $1,460,639 )
2013	2013	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	2	7/22/2013	NON-COMPETING CONTINUATION	$1,460,639
2013	2012	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	3/7/2013	NEW	$0
														Subtotal = $1,460,639

Issue Date FY: 2012 ( Subtotal = $1,553,871 )
2012	2012	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	002	1	7/26/2012	NEW	$0
2012	2012	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	1	7/2/2012	NEW	$442,771
2012	2012	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	3/19/2012	NEW	$1,111,100
														Subtotal = $1,553,871

Grand Total All Awards = $6,505,841

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Development of a Manufacturing Process for a Novel TB Vaccine

Award Number: R01AI098911

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/20/2012

PERIOD OF PERFORMANCE END DATE: 06/30/2018

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