Partnering To Bring Countermeasures To The Clinic

 
 

Working with the PBF leverages decades of understanding and a record of accomplishment in the manufacture of cGMP vaccines and biologics. The PBF has produced over 1800 lots of cGMP material. The PBF works closely with each client to facilitate smooth and efficient technology transfer. Our reliable manufacturing processes permit timely regulatory filings and clinical trials. Experienced staff and state-of-the-art equipment, including 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 to academic institutions and biopharmaceutical enterprises of all sizes. 

 


 

 

 

Capabilities

 
 
         
   
  • BSL-2 fermentation (up to 400 L scale)
  • Harvest/cell separation
  • Purified protein production in mammalian cells, bacteria, and yeast
  • BSL-2 live virus production and inactivation
  • Fixed bed bioreactor
  • Purification, conjugation 
   
  • Formulation & fill/finish, including lyophilization 
  • Analytical/Quality Control
  • Viral assays/clinical immunogenicity testing
  • Stability studies
  • Quality Management System, full cGMP compliance for Phase 1
   


 

 
     

Case Study: Rapid Process Development and Manufacturing of a Pan- Coronavirus Vaccine

 
     
  • Mammalian Cell Line: Development cells are expanded under optimized growth conditions
  • Transfection for Protein Expression: Cells are transiently transfected to express a Spike Ferritin Nanoparticle (SpFN) protein
  • Harvest & Purification: Cells are harvested and the SpFN protein is purified 
  • Formulation and Fill: Bulk vaccine is formulated and dispensed into vials 
  • Quality Control: The vaccine is tested, then released for use in Phase 1 clinical studies
  • Stability: Stability studies continue while the product is in clinical testing