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Pilot Bioproduction Facility
Welcome

The Pilot Bioproduction Facility's (PBF) mission is research, development, production, and testing of vaccines for human use. The PBF at Forest Glen is a multi-use facility designed and operated for production of 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 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.

The Pilot Bioproduction Facility (PBF) offers manufacturing of clinical grade material for clients in the public and private sectors through cooperative research and development agreements. Since 1958 as the Department of Biologics Research, the PBF has specialized in developing vaccines for DoD mission-related disease threats, especially infectious diseases, by following all federal regulations which apply to biological products. The PBF guarantees quality assurance during the en tire process of vaccine development- compliance, cleanliness, and safety are top priorities. Experienced staff and modern equipment assure the integrity of vaccines. Classified-air cleanrooms are used for seed preparation, fermentation, purification, and filling.

     Services
     Birth of a Vaccine
     Partnering to Bring Vaccines to Market
     Successes
     Types of Products
     Contact Us
     Frequently Asked Questions
Overview

The Pilot Bioproduction Facility (PBF) located at the Walter Reed Army Institute of Research (WRAIR) offers manufacturing of clinical grade material for clients in the public and private sectors. The PBF follows all federal regulations that apply to biological products and has expertise in the development and production of vaccines for the prevention of a variety of infectious diseases.

Established in 1958 as the Department of Biologics Research, the PBF has specialized in developing vaccines for DoD mission-related disease threats. Recently projects for public and private partners have been accomplished through inter-agency and cooperative agreements.

The vaccine development process is complex but the experienced PBF staff will ensure that each step is completed successfully.


Services
Pilot-scale production for Phases 1 and 2
         Cell Seed/Bank Production
         Fermentation
         Purification
         Formulation/Vialing/Freeze-drying
         BSL-2
Comprehensive pre-clinical QC testing
         Protein concentration
         Purity
         Potency
         Identity
         Sterility
         Endotoxin
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Birth of a Vaccine

The PBF guarantees quality assurance during the entire production process: compliance, cleanliness, and safety are top priorities. Experienced staff and modern equipment ensure the integrity of the vaccines. Classified-air clean rooms from Class 100,000 to 100 are used for seed preparation, fermentation, purification, and filling.

At the end of the process, the vaccine is tested for safety, potency, and identity; it is then released for use in approved human clinical studies.

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Partnering to Bring Vaccines to Market

Forming a partnership with the Pilot Bioproduction Facility (PBF) is an asset for any researcher, agency, or pharmaceutical company with a requirement for pilot-scale GMP production. The experienced staff works closely with a client's principal investigators to facilitate a smooth and efficient project. The application of GMP and GLP, along with proven management techniques, ensure that all vaccine products are manufactured, monitored, and tested according to specifications during each development phase. Reliable scheduling of production allows timely regulatory approval and planning for clinical trials. Together, researchers, manufacturers, and the PBF can produce vaccines efficiently and within authorized funding allocations.

Partners
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Successes

In the facility's distinguished history, the PBF has received awards and accolades for its role in developing vaccines for diseases like hepatitis A and meningitis. More recently, the facility has played a key role in the development of vaccines for dengue fever, malaria, HIV, cholera, and shigellosis.

Several of these experimental vaccines have progressed on to advanced clinical testing. Our field sites span across the globe to include Germany, Africa and Thailand. The local Clinical Trials Center at the Walter Reed Army Institute of Research tests many of the vaccines produced at the Pilot Bioproduction Facility.

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Types of Products

  • Recombinant subunit vaccines
  • Live-attenuated viral vaccines
  • Live-attenuated bacterial vaccines
  • Inactivated bacterial and viral vaccines
  • Skin test antigens
  • Therapeutic proteins
  • Adjuvants, placebos
TypesOfProducts.jpg
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Contact Us

Walter Reed Army Institute of Research
Pilot Bioproduction Facility
503 Robert Grant Avenue
Building 501
Silver Spring, MD 20910-7500

Main Number: (301) 319-9152
Fax Number:  (301) 319-9360


Directions

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Frequently Asked Questions
  • What are the PBF's capabilities/services?
  • What does the PBF have to offer?

  • What are the PBF manufacturing capacities?
  • How long will it take the PBF to produce a clinical grade product?
  • Can the PBF handle any portion of a manufacturing process?
  • How often is the facility audited?
  • How does private industry deal with a government facility?
  • How many people are employed at the PBF?
  • How can I arrange a tour of the PBF?
Download PDF Icon answers to FAQs.
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Last Modified Date: 09-September-2016



This Web site provides an introduction to the U.S. Army Medical Research and Materiel Command (USAMRMC) and contains official Government information. Its use is intended for members of the general public, news media and Army Medical Department beneficiaries.
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