Center for Gene Therapy

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Tulane cGMP Laboratory in Partnership with the Louisiana Gene Therapy Research Consortium

Introduction

The Tulane University Center for Gene Therapy was formed within the Tulane University Health Sciences Center in 2000. The major aim of the Center is to develop new therapies for a series of common illnesses that include osteoporosis, osteoarthritis, emphysema, Parkinsonism, spinal cord injury, heart disease, stroke and Alzheimer 's disease.

The Center has developed a 2,400 sq. ft. cGMP Laboratory with almost 1,000 square feet dedicated to aseptic manufacturing. The cGMP laboratory produces and distributes MSCs for use in approved clinical trials adhering to the federal regulations for Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP) and Biological Products utilizing Standard Operating Procedures (SOP 's).

Offer of Autologous Stem/Progenitor Cells (MSCs) for Clinical Trials

The Center for Gene Therapy at Tulane University Health Sciences Center is preparing to offer stem/progenitor cells (MSCs) for use in Phase I/II clinical trials. The Center is accepting bone marrow aspirates from patients and is able to produce 100 million or more MSCs within two to three weeks. The Center seeks collaborations with clinical investigators in the continental U.S. who wish to generate INDs for therapies with MSCs.

For more information, please contact: Center for Gene Therapy, Tulane University Health Sciences Center, 1430 Tulane Avenue, SL-99, New Orleans, LA 70112;

E-mail: msc@tulane.edu;

Tel: 504-988-7711

Facility Information

The cGMP Laboratory at Tulane University is housed in the Tidewater Building in the downtown area of New Orleans, Louisiana. Situated on Canal Street, the Tidewater Building is in close proximity to Tulane University Health Sciences Center, Louisiana State University School of Medicine, Tulane University Medical School, Charity Hospital, and the Tulane University Hospital.

The cGMP laboratory is located on the 21st floor and occupies approximately 2,400 sq. ft of total space. Of this, approximately 1,000 square feet is dedicated to aseptic manufacturing. This area of the laboratory is a traditional non-unidirectional turbulent airflow cleanroom with HEPA filtered air and established positive pressure gradients between adjacent rooms and the outside of the facility. The facility has controlled access for entrance and enforces unidirectional traffic flow patterns for personnel, materials, products, and waste. The manufacturing area houses four dedicated production rooms located off of a shared corridor and also contains a gown in room and materials pass through room which also serves as the main exit from the facility.

Each of the production suites contains 8 Thermo-Forma water jacketed incubators model 3130, 2 Baker SterilGARD III Advanced Biological Safety Cabinets, model SG403, 1 Thermo-Forma centrifuge, model Centra-CL3 with a 4-place swinging bucket rotor model 243, and 1 Nikon phase contrast microscope model TE2000S. The remaining space is partitioned amongst administrative offices, material storage including a quarantine area, female & male shower and change rooms, a freezer room, a mechanical room which contains the facilities air handling units, and a modern QC laboratory, equipped with incubators, rapid Endotoxin detection plate reader, Guava flow cytometer for cell counting, pH meter, and various other laboratory equipment.  

The objective of the cGMP laboratory is to produce and distribute MSCs for use in approved clinical trials. As such it is critical that these materials be of the highest quality, be safe, and posses the strength, identity, purity, and potency that they purport to have. To achieve this, all cGMP operations are designed to reflect the federal regulations for Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP) and Biological Products. As such, all operations or procedures that occur are conducted according to authorized Standard Operating Procedures (SOP 's). SOP 's for personnel, raw materials, the facility, equipment, production techniques, and quality control assays are currently in place.

Take a virtual tour of the cGMP laboratories.

Tulane Center for Gene Therapy

Contact Information

Center for Gene Therapy

Tulane University Health Sciences Center

1430 Tulane Avenue, SL-99

New Orleans, LA 70112-2699

Tel:   (504) 988-7711

Fax   (504) 988-7710

Email:   cgt@tulane.edu

Web:   www.genetherapy.tulane.edu

Ordering: http://www.genetherapy.tulane.edu/distribute.shtml

Statement of Policy on Equal Opportunity and Affirmative Action, Including Veterans and Disabled Individuals:

Tulane University is an educational institution committed to affirmative action and equal employment opportunity, as stated in the Tulane University Mission Statement, which includes, the following principle: “Tulane is strongly committed to policies of non-discrimination and affirmative action in student admission and in employment.”