Facility Requirements for a Cell Therapy Laboratory
Program Code: 054582
Wednesday, June 1, 2005
2:00 PM to 3:30 PM (ET)

MODERATOR
John D. McMannis, Ph.D., The University of Texas MD Anderson Cancer Center

SPEAKERS
Doug Padley, MT(ASCP), Mayo Clinic
Kathy Loper, MHS, MT(ASCP), AABB
Darin Weber, PhD, Biologics Consulting Group

DESCRIPTION
Existing and proposed regulations, including current good manufacturing practice (cGMP) and current good tissue practice (cGTP), contain facility requirements. The speakers will review room classifications with a focus on facility requirements in relation to the type of cell therapy product manufactured and to the phase of the clinical trial. In addition, environmental monitoring and facility sanitization will be discussed for facilities managed under cGMP regulations and for "unclassified" facilities.