Our Facilities
About the Cell Therapy Laboratory
The Cell Therapy Laboratory (CTL) facility (15,000 ft2) was completed in 2003 and is located on the 14th floor of the MDACC Lutheran Pavilion Building, with elevator access by using the “E” or “PB” elevators. CTL tours are available upon request and registration. Click on our floor plan for an expanded view.
The CTL is centrally located within the MD Anderson Cancer Center complex, with approximately ten (10) minutes of transport time to all product administration areas, including the Apheresis Clinic, Alkek Inpatient Units, Ambulatory Treatment Center (ATC) and Clinical and Translational Research Center (CTRC). All buildings are connected through environmentally controlled sky bridges that minimize temperature and humidity fluctuations.
The facility is certified annually to Class 7 ISO 14644-1 standards, including measurements of airflow, velocity, differential pressure, temperature, relative humidity, and fungal/bacterial airborne dynamic sampling and settling plates for the past 15 years.
Core Laboratory and External Sponsored Protocols
External Corporate Sponsored IND Protocols
Open concept cell therapy laboratory with concentration on Standard of Care minimal manipulation (361) activities as well as External Corporate Sponsored IND Protocols. These activities include: MNC preparations, enrichment and depletion of cells, product pooling, cellular product washing, plasma reduction, cryopreservation, thawing and preparation for infusion, shipping/receiving of LN2 dewars and cryopreservation storage (LN2 vapor phase). Some equipment includes Biosafe Sepax II, Terumo BCT Spectra Optia System, COBE 2991 Cell Separator, Sysmex XN-1000 Hematological Analyzer, Miltenyi CliniMACS Prodigy, Miltenyi CliniMACS Systems and the Terumo Sterile Connecting Device (TSCD).
Common Policies / Standard Operating Procedures Available For Review
- P03.23 Receipt, Transportation and Release of Products Manufactured at Non-MDACC Facilities
- P03.06 Product Receipt
- P03.09 Cell Product Storage and Disposal
- P03.10 Transportation of Cell Products
- Others policies/SOPs available upon request
Routine Equipment Used
- LN2 Vapor Phase Cryogenic Storage Tanks
- Water Baths
- Transport Containers (room temperature and <-150 C)
- Sysmex-XN Automated Cell Analyzer
- Planer Controlled Rate Freezer
- Centrifuge
- COBE 2991
- Environmentally Monitored Equipment
- Refrigerators
- Freezers
- LN2 tanks
- Incubators
Commonly Used Room Designations
- P14.2910 – Product shipment and receipt. Contains nine processing bays with class IIA Biological Safety Cabinets
- P14.3140 – Product storage area
Steps for ESP Approval
- Presentation of protocol to CARTOX team
- Presentation of protocol to CTL Management team
- Submit investigational brochures/ manuals for CTL review
- Sponsor site qualification tour of CTL (optional)
- Upon protocol approval, itemized budget generated
- Schedule Site initiation visit (SIV)
- Schedule training/ dry run with CTL personnel
- Patient enrollment
Routine Monitoring and Audits
Monitoring and audits of the operations of the CTL can be scheduled, with advanced notice required. The scope of the visits/audits will be based on the services provided by the CTL to the sponsor/industry partner, and according to mutually agreed upon industry standards.
Please contact Morgan Straubel at mkmills@mdanderson.org or Kara McGee at kmmcgee@mdanderson.org for monitoring visits. For audits, please contact Kara McGee at kmmcgee@mdanderson.org, F. Enrique Alvarez at fealvarez@mdanderson.org and Ping Fu at pfu@mdanderson.org.
Good Manufacturing Practices (GMP) Facility
Internal Investigator-Initiated IND protocols
Cleanroom facility (Class ISO 7) with 11 suites (8 positive pressure and 3 negative pressure) dedicated to the manufacture of cell and gene therapy products classified as more than minimal manipulation (351) and other investigational new drug (IND) products under current Good Manufacturing Practices (GMP), as described in Title 21 of the Code of Federal Regulations, parts 210, 211 and 1271. We have expertise in manufacturing investigational products for Phase I, II and III trials. Equipment available in the GMP suites include the GE Xuri W25 Cell Expansion System, Terumo BCT Quantum, Biosafe Sepax II, Miltenyi CliniMACS System, Baxter Baxa Repeater Pumps, COBE 2991 Cell Separator, Tap Biosystems Fill-It Automated Vialer, Terumo BCT Elutra Cell Separator and the CellRad Faxitron X-Ray Irradiator.
Common Policies / Standard Operating Procedure - Available Upon Request
Routine Equipment Used
- GE Xuri W25 Cell Expansion System
- Terumo BCT Quantum
- Biosafe Sepax II
- Miltenyi CliniMACS System
- Baxter Baxa Repeater Pumps
- COBE 2991 Cell Separator
- Tap Biosystems Fill-It Automated Vialer
- Terumo BCT Elutra Cell Separator
- CellRad Faxitron X-Ray Irradiater
Commonly Used Room Designations
- P14.3140 – Product storage area
Flow Cytometry Laboratory
CAP-accredited laboratory performing quality assessment of products (no patient diagnostics) in support of clinical trials and IND protocols. This laboratory performs immunophenotyping assessments for IND protocols, release criteria testing, engineering runs, protocol validation and product qualifications. Equipment includes BD FACSCanto II and Applied Systems Real Time qPCR.
Common Policies / Standard Operating Procedure - Available Upon Request
Routine Equipment Used
- BD FACSCanto II
- Applied Systems Real Time qPCR
Commonly Used Room Designations
- P14. 2911
Quality Control Laboratory
Environmental Controls and Monitoring
This laboratory performs In-Process and Release Criteria testing in support of our clinical trials and IND protocols. Quality assessment of the products is also performed for validations, qualifications, engineering runs. Additional duties also include performance of Environmental Monitoring activities (APCs, AMS, Settling and RODAC plates, Biofilm assessments); Equipment Management (IQ/OQ/PQ, repairs, certifications, calibrations, retirement, etc.) and Reference Lab Sample Management. Equipment includes Charles River Endosafe PTS, Lonza MycoAlert + Lucetta Luminometer, Malvern Zetasizer and Nanosight Particle Analyzers, Ergo Touch Pro 2 Airborne Particulate Sampler, SAS Super 180 Airborne Microbial Sampler and REES Environmental Monitoring System.
Common Policies / Standard Operating Procedure - Available Upon Request
Routine Equipment Used
- Charles River Endosafe PTS
- Lonza MycoAlert + Lucetta Luminometer
- Malvern Zetasizer Particle Analyzer
- Malvern Nanosight Particle Analyzer
- Ergo Touch Pro 2 Airborne Particulate Sampler
- SAS Super 180 Airborne Microbial Sampler
- REES Environmental Monitoring System
Commonly Used Room Designations
- P14.3010
This laboratory also maintains performance of Environmental Monitoring activities (APCs, AMS, Settling and RODAC plates, Biofilm assessments); Equipment Management (IQ/OQ/PQ, repairs, certifications, calibrations, retirement, etc.) and Reference Lab Sample Management.
Quality Assurance Unit
This group’s duties include, but are not limited to, Regulatory Compliance submissions (FDA, CBER, IRB, IBC, etc.), Quality Plan development and management, CMC development in support of IND/IDE protocols, Review and Approval of Validation Plans and Reports, Issuance of Certificates of Analysis on final products, Review of manufacturing/infusion records, Quality audits, internal/external, risk assessments; Document control and management; Deviation management and CAPA and Laboratory Accreditations (FACT, CAP, CLIA, etc.).