The Pilot Bioproduction Facility (PBF) is a cGMP-compliant pharmaceutical manufacturing facility located in Silver Spring, MD, at the Walter Reed Army Institute of Research. Completing extensive renovations in 2020, it has 12,500 sq. ft. of process, labs and support areas, of which 9,000 sq. ft. is cleanroom space. Established in 1953 as the Department of Biologics Research, the PBF specializes in developing vaccines and biologics for military-relevant infectious disease threats. That mission has since expanded to include contract management organization activities with public and private partners through cooperative agreements. The PBF’s experienced staff can help guide your vaccine through the development process! Learn more about your services below or through our fact sheet. Services Four process suites (~15,000 sq. ft.) BL-2 microbial fermentation (400 L scale) Microbial harvest & purification Live virus upstream, harvest and purification Formulation & fill / finish Support & preparation areas / QC and QA Viral assays / clinical immunogenicity Stability studies Partnering to bring vaccines to the clinic A collaboration with the PBF brings decades of understanding and a track record of success in the manufacture of GMP and non-GMP batches of vaccines and biologics. The PBF works closely with each client to facilitate smooth and efficient technology transfer. Our reliable manufacturing processes permit timely regulatory filings and effective clinical trials. Experienced staff and state-of-the-art equipment, including classified-air cleanroom spaces, assure reliable production with compliance and safety as top priorities. Through our decades-long history, we have successfully worked with a diverse array of collaborators, from government and military facilities to academic institutions and biopharmaceutical enterprises of all sizes. Successes PBF support has been critical to the development efforts of the Department of Defense in the advancement of numerous vaccines. These vaccines include those for hepatitis A, meningitis, dengue fever, malaria, adenovirus, Japanese encephalitis, shigellosis, zika, and, most recently Covid-19. Several of these experimental vaccines have progressed to advanced clinical testing and licensure. Types of Products Live, attenuated or inactivated bacterial/viral vaccines Purified protein production in mammalian cells, bacteria, and yeast Conjugate vaccines Nucleic acid vaccines (DNA and mRNA) Cell banking, including mammalian cell banks, bacterial, viral, and parasite seed banks Contact Us Walter Reed Army Institute of Research Pilot Bioproduction Facility 503 Robert Grant Avenue Building 501 Silver Spring, MD 20910-7500 Email: usarmy.detrick.medcom-wrair.mbx.pilot-bio-production-facility@health.mil Main Number: (301) 319-9152 Frequently Asked Questions What are the PBF's capabilities and services? Click here for more information about specific capabilities. The PBF can handle any step of a manufacturing process from cell and virus seed banking to filling. It can perform BSL-2 fermentations as well as BSL-2 viral propagations & filling. All rooms in the PBF are capable of vapor phase hydrogen peroxide decontamination and waste from the BSL-2 fermentation suite is transferred to a waste inactivation system before release for disposal. The PBF is capable of 400 liters of microbial fermentation and 2000 vials/lot of finished product. With decades of experience, the PBF can successfully transition your product into advanced clinical trials and licensure. How long will it take the PBF to produce a clinical grade product? It usually takes less than a year to schedule a production slot in the PBF. After the technology transfer is completed, actual production time depends on the specific project but is typically less than a year in duration. Can the PBF handle any portion of a manufacturing process? Yes, from cell & virus seed banking to filling. How does private industry deal with a government facility? The PBF has a flexible and well-established approach to rapidly develop, process, and execute agreements with private industry. How many people are employed at the PBF? Approximately 50 staff. How can I arrange a tour of the PBF? Contact us by clicking here or e-mail usarmy.detrick.medcom-wrair.mbx.pilot-bio-production-facility@health.mil