Quality Control Laboratory
The Quality Control (QC) Laboratory is staffed by a coordinator and six analysts who perform and coordinate testing on cell and gene therapy products manufactured by the CAGT
In-house tests include:
- Endotoxin (LAL)/EndosafeTM
- Mycoplasma by PCR
- Epstein-Barr Virus by Real Time PCR
- Vector Identity
- Cell Growth
- Adenoviral titers
- Replication-competent adenovirus testing
- Bioburdens
- Environmental monitoring
- Particle counts
- Viable counts
- Surface monitoring
- Fallout plates
The staff also coordinate contract testing of vector and cell therapy products by a number of commercial companies. They are experienced in the shipment of therapeutic products to institutions worldwide.
They assist in ensuring that the manufacturing facilities comply with Good Manufacturing and Good Tissue Practices.
The QC Laboratory has performed contract testing for:
- Baylor College of Medicine Investigators
- Texas Medical Center institutions
- Biotechnology companies
For additional information contact Deborah Lyon dllyon@txccc.org
For contract manufacturing contact Myrlena Lee myrlenal@bcm.edu