Quality control services are provided to the CAGT GMP facilities by a dedicated Quality Control Laboratory staffed by seven analysts. This 1,000-square-foot facility with dedicated en suite laboratories for cell culture and real time quantitative PCR, was opened in 2010. It provides an extensive program of environmental monitoring for the clean rooms in addition to testing of in-process and release testing for vectors and cellular therapy products. The laboratory performs in-house testing, shown below, in addition to coordinating send-out testing to commercial laboratories.
In-house testing includes:
- Endotoxin - LAL
- Mycoplasma by PCR
- Bioburden
- Viral titer by CPE
- Viral particle titer
- RODAC testing
- Replication-competent adenovirus
- Replication-competent retrovirus
- EBV - by real time PCR
- pH
- Particle and viable counts
- Fallout plate testing
Contract testing has been performed for a number of academic institutions.
The QC Laboratory is also responsible for the storage and release of investigational cell therapy and vector products, and for shipment of these products to investigators worldwide.
For additional information contact Deborah Lyon.
