The Research & Development team has several areas of focus and a broad range of expertise. Scientists have specialization in immunology, virology, microbiology, cellular and molecular biology, cell and tissue engineering, biomaterials, and proteomics.
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 more than 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 15,000 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 consistency from starting material to release of final product.
The R&D team works with therapeutic developers to help them modify and optimize their process prior to transferring to process development under a CDMO.
The R&D team has a broad range of expertise that supports the development of new products and services for BioBridge Global. 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. Most recently the organization launched a full range of cGMP starting materials for Advanced Therapies.
The R&D team is often sought-after for their expertise in various collaborative grant ventures. The organization has submitted grants to local and national funding agencies and partnered with biotech companies, military and academic institutions.