Clinical Wing

Research-grade materials are produced in a 2040 sq. ft. facility that consists of six separate laboratory rooms, an equipment room, a cold room, a materials storage room and an administrative office. Access to the facility is controlled by lock and key and is limited to authorized personnel. The facilities have separate rooms for producing various types of vector platforms including AAV, Adenovirus, Lentivirus, Retrovirus and cell-based products. The facilities are also used for process development, Quality Control assays and manufacturing of bacterial products under cGMP.

The procedures used in the Research Wing are integrated into the Standard Operating Procedures (SOPs) and Qualilty Control systems used for clinical manufacturing. This control infrastructure allows additional quality control mechanisms to be readily applied if a higher level of characterization or documentation is desired for a specific product. Applying control mechanisms in a logical manner to match the grade of the materials serves to enhance the overall quality and lot-to-lot consistency of research and pre-clinical materials. A complete list of the SOPs and Quality Systems used by the JVL are provided online.

Research-Grade Vectors

Small, standard sized preparations of research grade material for set price
Provided with a guarantee of purity and titer within specified ranges
The facility can produce AAV, Adenovirus, Lentivirus and plasmid vectors
Aliquots of GFP, luciferase or LacZ control vectors are also available

Pre-Clinical-Grade Vectors

Large-scale preps for formal Pharm/Tox and Bio-distribution studies
Manufactured following the cGMP guidelines
More extensive lot release criteria and testing specifications
Investigators are provided with a Pre-Clinical Material CMC Report
Priced individually on the basis of pilot lots to determine vector yield
Can be customized

UNC Gene Therapy Center Contact Information