What address is used for sponsor related shipping materials/supplies, leukapheresis pick-up location and investigational product receipt?
Morgan Straubel/Kara McGee
MD Anderson Cancer Center
1515 Holcombe Blvd., Room P14.2910
Lutheran Pavilion Building, Floor 14,
Houston, Texas 77030
Where are the products for Externally Sponsored Protocols handled/ prepared?
The products for Externally Sponsored Protocols are handled/prepared in the Core Laboratory.
How many biosafety cabinets are located in the Core Laboratory?
9 Class IIA Biosafety Cabinets are located in the Core Laboratory, room P14.2910.
How many fume hoods are located in the Cell Therapy Laboratory?
The Cell Therapy Laboratory has one chemical fume hood for general use, room P14.3124.
Is the facility able to store products in vapor phase LN2? How Long?
The facility is able to store investigational product temporarily in vapor phase LN2. Typical storage time frames range from two days to one month.
Does the facility have access to secured, adequate cryogenic storage space?
Yes, P14.3140 is our LN2 vapor phase storage tank area. This room requires badge access entry and all LN2 tanks are secured with padlock.
Is the facility able to accommodate external sponsor-provided equipment, such as thawing devices?
Unfortunately, the Cell Therapy Laboratory is unable to accommodate sponsor-provided equipment.
Do you offer tours of the facility?
Does the Cell Therapy Laboratory have secured access to prevent unauthorized entry?
Yes, the Cell Therapy Laboratory has secured access at the main entrance and all laboratory areas.
Is the facility supported by an emergency power supply?
Yes, all Cell Therapy Laboratory equipment is supported by emergency power supply.
Is environmental monitoring available on a 24/7 basis?
The REES Scientific Automated Monitoring System which records temperature, humidity, differential pressure, carbon dioxide, oxygen, etc., provides continuous (24/7/365) monitoring of refrigerators, freezers, LN2 tanks, incubators, etc. Temperature graphs available upon request.
Does the facility comply with current Quality Systems regulations and practices?
Does the facility use validated containers to transport cellular therapy products?
Yes, all transport containers are validated for the appropriate temperature ranges.
Are cryopreserved products typically thawed in the lab or at the bedside?
Thawing in the lab or at bedside is protocol specific for infusion preparation.
What is the typical number of processing/handling staff available per trial?
Typically, the Cell Therapy Laboratory selects a group of approximately four staff members to focus on the logistics, handling, and preparation of products for each trial.