About The Pilot Bioproduction Facility

 
  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, and producing Good Manufacturing Practice (GMP) compliant material since 1993, the PBF specializes in developing vaccines and biologics for military-relevant infectious disease threats. That mission has since expanded to include collaborations with public and private partners through cooperative agreements. Between 2016-2020, the PBF underwent extensive renovations to expand and improve its state-of-the-art capabilities. Our vaccine and biologics capabilities include process development, scale-up, and Phase I GMP drug substance and drug product manufacturing.  


 
 

Contact Us

 




 



 
 

Quality Control

 
  • Environmental monitoring for regulatory compliance​
  • In-process manufacturing quality testing​
  • Product release analytical testing​
  • Drug Substance and Drug Product Stability testing​
 

 
   

ASAT/MSAT

 
  • Process scalability and GMP suitability assessments
  • Manufacturing process development
  • Technology transfer
  • Product specific analytical testing development
 

 
       

mRNA

 
mRNA Vaccine Production: in vitro transcription up to 300 mL scale, approximately 1 gram of mRNA  
 

 

   

Purification

 
  • Scalable recombinant protein purification expertise: depth filtration, chromatography, tangential flow filtration, and more 
  • Knauer NanoScaler™ for lipid nanoparticle encapsulation and liposome production ​
 
 

Viral

 
  • Viral Vaccine Production: BSL-2 attenuated and inactivated vaccine production
  • Master/Working viral banks (up to 200 vials each)
  • Live challenge viral strains
  • Univercells scale-X™ carbo fixed bed bioreactor 10-30m2 (cell growth area equivalent to 120-360 roller bottles or 16-48 cell stacks with 10 trays (e.g. CellSTACK™-10 layer))
  • Roller bottles – up to 40 roller bottles
  • Cell stacks – up to 10 cell stacks with 10 trays (e.g. CellSTACK™-10 layer)
  • Independent Air Handling to maintain closed environment
  • Vaporized Hydrogen Peroxide decontamination between campaigns
 

 
   

Non-Viral

 
  • Microbial fermentation – up to 400L scale
  • Mammalian cell culture – up to 40L scale
  • Master/Working cell banks (up to 200 vials each)
  • Bacterial challenge strains
  • Live attenuated bacterial vaccines
  • Stacked disk centrifuge (Alfa Laval model BTPX 305)
  • Hollow fiber and flat sheet tangential flow systems
 

 
       

Fill Finish

 
  • Final product formulation​
  • Viral and non-viral drug product filling​
  • Manual filling up to 2,000 vials per lot​
  • Lyophilization capability​
  • 2mL – 20mL vial sizes qualified​
 

 

   

Contact Us

 
503 Robert Grant Ave, Building 501
Silver Spring, MD 20910-7500
Main Number:
(301) 319-9152
USARMY.DETRICK.MEDCOM-WRAIR.MBX.PILOT-BIOPRODUCTION-FACILITY@HEALTH.MIL