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.
For more information, visit the core facility website.
David Curiel, MD, PhD, facility director
William Swaney, MS, operations director
Heather Missey, senior research technician and quality assurance
Robert Obermann, senior research technician
LOCATION: Southwest Tower, Room 717; Office: Southwest Tower, Room 719
TO ACCESS: Contact William Swaney at 314-362-9011 or e-mail firstname.lastname@example.org
As of April 7, 2008, the NIH requires investigators with a publication using Siteman (or other NIH-funded) shared resources to submit (or have submitted for them) their final, peer reviewed manuscripts to PubMed Central(PMC) upon acceptance of publication, to be made publicly available within 12 months of publication. Many journals automatically submit these for authors, but Washington University also has assistance available through the Becker Medical Library. Please see http://publicaccess.nih.gov/FAQ.htm#b7 or http://becker.wustl.edu/classes-consulting/specialized-expertise/nih-public-access-policy for more information.
PUBLICATION ACKNOWLEDGEMENT: If research supported by the Biologic Therapy Core Facility results in publication, please acknowledge this support by including the following in your publication(s):
We thank the Alvin J. Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis, Mo., for the use of the Biologic Therapy Core Facility, which provided __________ service. The Siteman Cancer Center is supported in part by an NCI Cancer Center Support Grant #P30 CA91842.