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
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.