Custom Services

Our R&D group leverages the knowledge and experience of 2 Transfusion Medicine boarded physicians and 9 PhDs.

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.

Access to Biomaterials

While our priority will always be to serve the needs of our community, we are eager to collaborate with research institutions and to provide products for research (subject to availability and consent verification), including:

  • Whole Blood
  • Red Blood Cells
  • Platelets
  • Plasma
  • Buffy Coats
  • Cryoprecipitate
  • Leukochambers
  • Peripheral Blood Stem Cells (PBSCs)
  • Peripheral Blood Mononuclear Cells (PBMCs)
  • Cord Blood
  • Perinatal Tissue (Umbilical Cord or Placenta)
  • Cadaveric Tissue

Please complete the Request for Access to Biomaterials Form, sign it and email it to Biomaterials@BioBridgeGlobal.org.

 

We will contact you upon receipt and review of your request.

Research & Development

The R&D team has a long track record and extensive experience in custom assay development with assay types ranging from ELISA to Flow Cytometry to Nucleic Acid Testing to Cellular Interaction and Potency Testing. One example is the Beacon assays that were internally developed to detect Parvovirus B19 and hepatitis A virus via nucleic acid testing with a full FDA device master file submitted. This assay was used for years as a gold standard in the source plasma industry for product safety testing. More recently a T-regulatory assay has been developed to assess the effect of cellular therapy products on the activity of CD4 and CD8 T-cells.

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.

The R&D team has worked with many customers to develop individualized quality control testing for lot and final product release. Often the assays used for donor qualification of starting materials can be individualized for this QC testing, providing consistence from starting material to release of final product.
The R&D team has a range of expertise to bring to bear on product development, with the current focus on the development of commercially viable products from source materials within the organization. One example is the development of a patent pending cell expansion media from platelets. Initial data support this media performing superior to the currently available lysates on the market. Another is the development of an amnion patch that has been sterilized via super-critical CO2 instead of the traditional gamma irradiation, with traditional gamma irradiation often damaging the tissue and decreasing the protein content by as much as 25%.
The R&D team is often sought after for their expertise in various collaborative grant ventures. The team is currently participating in an MTEC funded grant with Southwest Research Institute investigating 3D-printed perfusion bioreactors to produce exosomes. In addition, the team has recently submitted a grant to the San Antonio Medical Foundation in collaboration with Texas BioMedical Research Institute and StemBioSys on human tissue culture-based models to accelerate drug development for lung diseases with the team’s focus being on assay development and microfluidics.

Clinical Trial Support

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.

Case Study

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:

  • Qualify as an apheresis collection site for their clinical trial
  • Develop partnerships and communication plans with local hematology/oncology physicians
  • Develop all internal SOPs in accordance with their protocol, in a cGMP compliant fashion
  • Consistently report on clinical trial activity for our partner to provide to their IRB and the FDA

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.

Publications

Our team of scientists authored many publications.

Commitment to Quality
Quality has been a guiding principle within our organization for more than 45 years.
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Certifications
Our organization complies with multiple U.S. and international standards. A full list of accreditations, certifications and registrations can be found here.