The Quality Control Unit is directly involved in the release and stability testing of all vaccine products in development at Texas Children's Hospital Center for Vaccine Development. Quality Control works in direct collaboration with the Analytic Development Unit using qualified assays to evaluate purity, stability and identity of the target products. This involves biophysical characterization of the antigen, evaluation of stabilizers, investigation of antigen interactions with adjuvants, evaluation of product contact materials, and monitoring stability both in real time and under accelerated conditions. Because the vaccine targets often thrive in tropical areas of high poverty, there is a need to ensure that the vaccine formulation can be stable for a relatively long period of time on the shelf once in the clinic.
The Quality Control Unit is currently implementing new assays that can be used to evaluate the stability of the product in tropical conditions. Recent work has focused primarily on hookworm vaccines. The Unit has been responsible for performing all stability testing of the Na-GST-1 protein and Na-APR-1 protein. The unit is also involved in a schistosomiasis vaccine project as well as Chagas disease, MERS, and SARS development projects.
The Quality Control Unit also collaborates with third-party manufacturers during manufacturing prior to tech transfer.
Laboratory Facilities
The Quality Control Unit shares laboratory collaborative laboratory space in Texas Children's Hospital Center for Vaccine Development.
Credit
Unit Director
Wen-Hsiang Chen, Ph.D.
