The mission of the Process and Development Laboratory of PGTC (PD) is to develop methods for large-scale manufacturing of rAAV stocks in a GMP-translatable manner. The methods currently utilized in this group is the HSV coinfection method and the PEI co-transfection protocol, both using suspension cells grown in shaker flasks or single use bio-reactors.
Quality Control Lab
The Quality Control Laboratory is responsible to perform or review all the testing required for GLP and GMP-grade rAAV stocks at GLP or GMP-level. The QC laboratory also assists with sample analysis of PD test runs. The PD and QC labs are also responsible for the production and release testing of all GLP grade stocks of Test Articles for IND-enabling studies using GMP-like protocols.