cGMP Clinical Manufacturing

GMP manufacturing facility floor plan

The LGTRC is building a 9,200 sq.ft. clinical manufacturing facility (CMF) in New Orleans, Louisiana for manufacturing cell and gene therapy technologies for human clinical trials. The facility is required to meet the requirements for manufacturing therapies used in humans and will operate under federal regulations for current Good Manufacturing Practices (cGMP).

The facility is planned to produce materials for Phase I and II clinical trials and will support three categories of cell and gene therapy manufacturing:
• Cell Therapy – multiple simultaneous patient specific products
• Ex-vivo Gene Therapy – multiple simultaneous patient specific products
• Viral vector production – multiple products on a campaign basis

When the facility begins full operations in early 2010, it will offer one production train with a seed culture room, upstream processing room, downstream processing room and a fill/finish room. There will also be four cell therapy room, quality control rooms including an analytical lab, microbiology lab and a tissue culture lab and associated production support areas. The facility will be capable of providing material for pre-clinical and Phase I and II clinical trials.

The CMF will incorporate best practices from the contract manufacturing industry, such as the use of disposable supplies and portable equipment so cleanrooms can more easily be configured for multiple processes to meet customer needs

Requests for Clinical Manufacturing information should be directed to:
Business Development Manager