LGTRC/Tulane cGMP Facility
directed by Bruce Bunnell
(504) 988-3329
http://www.genetherapy.tulane.edu/cGMP.shtml
a member since 7/28/2009

Contact Info

For information contact
Sanjin Zvonic.

(504) 988-5303
Tulane University School of Medicine
1440 Canal Street
Suite 2140, TB-28
New Orleans, LA 70112

USA
(504) 988-5303
(504) 988-5329

Services Provided

This facility provides research grade material and offers production support to both Academics and Companies.

Misc Services

  • GLP and cGMP Manufacturing
  • GLP and cGMP Process Development
  • Pre-clinical Studies
  • MPR Development
  • Process and Material Validation
  • Cell and Tissue Banking
  • IND and Grant Submission Support
  • Regulatory Affairs Support
  • QA/QC Program Development
  • Clinical Manufacturing Training

Biologics Produced

  • working cell banks
  • Pluripotent Stem Cells
  • mesenchymal stromal cells
  • full GMP facility. Master cell banks

About this facility

Louisiana Gene Therapy Research Consortium (LGTRC)/Tulane Center for Gene Therapy (CGT) cGMP Facility was originally developed to meet the Center¹s need for the production of hMSCs for use in approved clinical trials adhering to the FDA current Good Manufacturing Practice (cGMP) regulations for Finished Pharmaceuticals and Biological Products.

At the present time, the cGMP Facility has the unique ability to support the advancement of translational/clinical research development within Tulane University, as well as the broader regional academic and biotech communities, by offering process/product development, validation and GLP/cGMP manufacturing services essential for key steps in the process of commercialization and clinical implementation of novel cellular therapies, adherent with current federal regulations.

The cGMP Facility 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 Facility 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, Endotoxin PTS, Cell Lab Quanta SC MPL for cell counting, pH meter, and various other laboratory equipment.