WRAIR Pilot Bioproduction Facility

The Walter Reed Army Institute of Research's (WRAIR) mission is research, development, production, and testing of vaccines for human use.

The Pilot Bioproduction Facility (PBF) at WRAIR Forest Glen is a multi-use facility designed and operated for production of Phase 1/2 level vaccine components and vaccines in compliance with current Good Manufacturing Practice (cGMP) regulations. 

Compliance with cGMP ensures that products prepared in this facility will be safe, potent, and reproducible.  Vaccines are produced for the military that will protect soldiers against diseases they may encounter in areas of deployment.  These products include vaccines to prevent shigellosis and other diarrheal infections, dengue, malaria, meningitis, and HIV.

In order to be mission ready, the PBF regularly works with other organizations and private companies through Cooperative Research and Development Agreements (CRADAs) to accomplish their Phase 1/2 vaccine manufacturing needs.  More than 1800 lots of vaccine material have been manufactured to date.
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Locations


United States
Silver Spring, MD
503 Robert Grant Avenue
Silver Spring, MD  20910
United States, North America

GMP Experience
19 years of Phase 1/2 manufacturing. Over 1700 lots of vaccine components and vaccines produced. Over 100 INDs initiated with WRAIR PBF manufactured material

Contacts


Rick Millward
Deputy Chief

Production Lines

Silver Spring, MD   Aseptic GMP Filling (Liquid)
Location: Silver Spring, MD, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  1-5,0001-5,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
Supported Vial Size:  20 ml20 ml
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Additional Services
Analytical Services are Not AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is Not AvailablePreclinical Manufacturing
Stability Studies are Not AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is AvailableViral Manufacturing
Availability: Available

Last Update: 19MAY17

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Silver Spring, MD   Aseptic GMP Filling (Lyophilization)
Location: Silver Spring, MD, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LyophilizedLyophilized
Batch Size:  1-5,0001-5,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
Supported Vial Size:  20 ml20 ml
Supported Vial Size:  20+ ml20+ ml
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Additional Services
Analytical Services are Not AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is Not AvailablePreclinical Manufacturing
Stability Studies are Not AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is AvailableViral Manufacturing
Availability: Available

Last Update: 19MAY17

Send Inquiry about this Production Line
Silver Spring, MD   300L Fermentation
Location: Silver Spring, MD, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L300L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Single Use:  NoneNone
Additional Services
Analytical Services are Not AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is Not AvailableCell Line Development
Preclinical Manufacturing is Not AvailablePreclinical Manufacturing
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 19MAY17

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Silver Spring, MD   30/60 L Fermentation
Location: Silver Spring, MD, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  1L-100L60L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Single Use:  NoneNone
Additional Services
Analytical Services are Not AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is Not AvailableCell Line Development
Preclinical Manufacturing is Not AvailablePreclinical Manufacturing
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 19MAY17

Send Inquiry about this Production Line
Silver Spring, MD   GMP Microbial Seed Production
Location: Silver Spring, MD, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Scale:  1L-100L1L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Single Use:  NoneNone
Additional Services
Analytical Services are Not AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is Not AvailableCell Line Development
Preclinical Manufacturing is Not AvailablePreclinical Manufacturing
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 19MAY17

Send Inquiry about this Production Line
Silver Spring, MD   Purification
Location: Silver Spring, MD, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Scale:  1L-100L30L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Single Use:  NoneNone
Additional Services
Analytical Services are Not AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is Not AvailableCell Line Development
Preclinical Manufacturing is Not AvailablePreclinical Manufacturing
Viral Manufacturing is AvailableViral Manufacturing
Availability: Available

Last Update: 19MAY17

Send Inquiry about this Production Line
Silver Spring, MD  
Location: Silver Spring, MD, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  1-5,0001-5,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
Supported Vial Size:  20 ml20 ml
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Additional Services
Analytical Services are Not AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is Not AvailablePreclinical Manufacturing
Stability Studies are Not AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is AvailableViral Manufacturing
Availability: Available

Last Update: 19MAY17

Send Inquiry about this Production Line

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