Quality Assurance

GMP manufacturing and quality control activities are under the auspices of an independent quality assurance group with extensive experience in GMP manufacturing of cellular products. They are responsible for the following activities:

Center for Cell & Gene Therapy - cGMP Facilities

SOP Generation

Document control &​ Record review

Generation of Certificates of Analysis

Product release

Regulatory compliance

Transition of protocols into GMP Facility 

Qualification and validation oversight

Proficiency and competency oversight
​Materials evaluation and management Audits Quality program development & management cGMP compliance Data trending
               

Quality Control


​Quality control services are provided to the CAGT GMP facilities by a dedicated QC 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 the following:
  • Endotoxin –LAL
  • ​​Bioburden
  • Viral titer by CPE
  • ​​Viral particle titer
  • Rodac Testing
  • Replication-competent adenovirus
  • Replication-competent retrovirus
  • EBV - by real time PCR
  • ​Particle and Viable counts
  • Fallout Plate testing
  • pH

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. Contract testing has also been performed for a number of academic institutions.



1102 Bates Street, Suite 1670

​Houston, Texas 77030