The Biologic Therapy Core Facility:

Maintains and operates an FDA registered modern pharmaceutical cleanroom facility dedicated to the manufacture of custom biologics and drugs under current Good Manufacturing Practices (cGMP) conditions.
Supports translational medicine efforts (from bench to bedside) in the fields of cellular therapy, gene therapy and other treatments by providing the infrastructure needed to conduct early Phase I/II clinical trials.
Develops and manufactures novel biologic, cellular and other state-of-the-art therapeutics for human administration under controlled conditions in accordance with the U.S. Food and Drug Administration and other regulations.
Labels MAB for use in Immuno-radiotherapy treatments or as PET imaging agents in oncological settings
Routine tissue processing and cryopreservation (e.g. cryopreservation of parathyroid tissue).
Provides Research grade Lentiviral vectors, and Recombinant Proteins to SCC Members.
Provides regulatory and administrative support in the therapeutic agent approval process.
The Biologic Therapy Core Facility also provides consulting services for Siteman Cancer Center members, Washington University faculty and interested academic and nonacademic entities in compliance with Good Manufacturing Practice rules and regulations, and with issues regarding the new Good Tissue Practice Act, which became effective in May 2005.