Our team has experience that spans all of the different phases of our organization’s end-to-end capabilities, including custom assay development, product development for applications in regenerative medicine, clinical trials support for our partners, including FDA approval of assays and equipment, collection and specialized processing of novel blood products.
With QualTex’s highly automated laboratory that results over 60 million tests per year, the R&D team has experience in taking a prototype assay from development to automation on a selected platform and scale-up for high throughput use of the assay. One example is the development of a highly automated 96-well isoagglutinin titer to support the military’s use of Low-Titer O Positive Whole Blood in trauma resuscitation. Another is the scale-up of a 384-well polymerase chain reaction (PCR) based assay for the detection of SARS-CoV-2 to perform 10,000 tests per day with a turnaround time of less than 24 hours.
Our team includes two Transfusion Medicine board certified physicians and 9 PhDs with specialization in immunology, virology, microbiology, cellular and molecular biology, cell and tissue engineering, biomaterials and proteomics. In total we have over 40 years of experience acting as Principle Investigator of internal and industry-sponsored IRB protocols. In aggregate we have successfully acted as PI on over 35 studies. These protocols range in topic from blood product collection and characterization to device assessment for FDA approval to assay performance assessment for FDA approval. Our team has participated in pre-clinical as well as all phases of clinical trial support. Many of these studies involved the collection of data submitted to the FDA for final approval of a device or assay.
A pharmaceutical company developed an immunotherapy for treatment of advanced stage prostate cancer using a patient’s own immune cells. They required partner sites that could collect the patient’s mononuclear cells through apheresis and ship for further manufacturing into the immunotherapy.
To support their clinical trial, we were able to:
Once our partner’s immunotherapy received FDA approval, we maintained our partnership and continue to provide apheresis collections for patients in South Texas. We also helped create a tool for other apheresis centers to follow to enhance their collections.
Our team of scientists authored many publications.