Pilot Bioproduction Facility

A bottle of pilot product from the PBF

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.  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.

Between 2016 and 2018, the PBF underwent extensive renovations to expand and improve its state-of-the-art capabilities. Full GMP operations will resume in the second half of 2019.

The PBF’s experienced staff can help guide your vaccine through the development process!

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 including lyophilization
  • Support & preparation areas / QC and QA
  • Viral assays / clinical immunogenicity
  • Stability studies
  • Tech transfer
  • 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, and, most recently, Zika.  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 vaccines
  • Bacteriophage production
  • Bacterial/viral/parasite seeds
  • Mammalian cells (anchorage- dependent)
  • Microbial cells (yeast, bacteria, BL-2)

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@mail.mil

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

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 5000 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 tie 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?

Once renovations complete, the current target is 40 staff. 

How can I arrange a tour of the PBF?

Contact usarmy.detrick.medcom-wrair.mbx.pilot-bio-production-facility@mail.mil