Product Development and Manufacturing  
 
     

Providing infrastructure and services to develop and manufacture vaccine, diagnostic and therapeutic products sufficient for preclinical and Phase I and II clinical trials, the Product Development
and Manufacturing (PDM) Core supports the Rocky Mountain Regional Center of Excellence for Biodefense and Emerging Infectious Disease Research.

Experienced personnel provide characterization of the potential product and optimization of the manufacturing processes and control assays under Good Laboratory Practice (GLP) management controls. Individualized services are provided, including support
of projects that require BSL-3 containment.

  
     
 
  Upon successful completion of the product development phase, the PDM Core has the capability to manufacture products under current Good Manufacturing Practice (cGMP) control systems that meet FDA regulatory standards for manufacturing and quality control testing. The capacity of the PDM Core is sufficient to support pre-clinical and early clinical (Phase I and II) development projects for most biological products.  
     
  Important Attributes  
     
 
  • BSL-2, BSL-3, and CDC Category A-C Select Agents  
       
  • 2100 sq. ft BSL-3 laboratory and manufacturing space  
       
  • 2300 sq. ft BSL-2 pilot plant space  
       
  • IQ, OQ, and PQ equipment qualifications  
       
  • Product hold, inventory, and short-term storage (cGMP-compliant vaporized LN2)

  
 
     
   
     
 
 
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