2004N-0408 - Regulatory Site Visit Training Program
  


  

  


  

  
FDA Comment Number : 
  

  
EC13
  



  

  

  



  

  
Submitter : 
  

  
Ms. Carol Bailey
  

  
Date & Time: 
  

  
10/23/2004 04:10:07
  



  

  
Organization : 
  

  
Xcyte Therapies
  



  

  
Drug Industry
  


  

  
Category : 
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Xcyte Therapies would like to request consideration under Docket No. 2004N-0408 for participation in CBER's Regulatory Site Visit Training Program.  Xcyte Therapies is a Seattle-based biotechnology company developing cellular therapeutic products designed to enhance the body's immune responses for treatment of cancer, infectious diseases and other medical conditions associated with weakened immune systems.  Xcyte Therapies is in the process of initiating a pivotal clinical trial and a commercial-scale cell-processing facility.  Xcyte believes we can offer CBER staff an opportunity to observe aseptic cell processing using novel WaveBioreactor(tm) technology to grow autologous T cells.  Review of our facility offers the potential to improve CBER's understanding of current practices, regulatory impacts and needs, and improve communications between CBER staff and industry.