San Antonio, Texas, Nov. 18, 2021 (GLOBE NEWSWIRE) -- BioBridge Global is committed to supporting advanced therapies through the development and delivery of services from source material collection, donor and product testing, development and manufacturing services and logistics management. This week, the organization fulfilled a promise to customers to collect, deliver and process an umbilical cord under current good manufacturing process (cGMP) standards for further manufacture into advanced therapies.
BioBridge Global has been collecting, testing, and delivering material under cGMP and/or cGTP for clinical use for more than 45 years. Birth tissues were added to that portfolio in 2016 for use in graft applications by numerous tissue processors. Therapeutic developers of advanced therapies have been requesting tissue under cGMP for further manufacture for several years, having found no consistent and reliable source in the United States.
The complexities associated with donor qualification, tissue collection and tissue processing for umbilical cord tissue are far greater under these further manufacturing standards. Donor mothers must be exceptionally healthy, already have been identified to undergo a planned c-section, and then consented under an IRB-approved consent. The cord tissue, collected during the birth process, is then tested independently to ensure sterility of the product going into therapeutic development. To deliver the best possible therapeutic product, the cord must undergo very specific preparation steps in a clean room environment before it is released for life-saving therapies. The processed cord, which is rich in stem cells, can eventually be manufactured into a combination of either intermediates such as a master cell bank or end-product advanced therapies to deliver directly to a patient.
South Texas Blood & Tissue collected the birth tissue from a donor who was determined eligible based on custom specifications as well as significant regulatory agency requirements for tissues used for further manufacture. QualTex Laboratories performed donor screening and sterility testing on the cell product, and GenCure conducted time-sensitive aseptic processing to ensure that the tissue-derived cell product could be preserved for maximum benefit for therapeutic development.
South Texas Blood & Tissue, QualTex Laboratories and GenCure are subsidiaries of San Antonio-based nonprofit BioBridge Global.
“This is a significant accomplishment for the entire organization and the teams involved,” said Martin Landon, Chief Executive Officer of BioBridge Global. “To the best of our knowledge, based on our review of the market and customer feedback, there is no source material provider in the United States delivering qualified birth tissue under cGMP for further manufacture into advanced therapies.”
Other organizations have programs using cells derived from umbilical cord, and various sources are available for early-stage research. But there were no consistent sources of cGMP collections and processing for further manufacture until BioBridge Global made its delivery. The market demand came to BioBridge Global’s attention when it developed its biomanufacturing service line under GenCure. A number of customers had approached GenCure, knowing about BioBridge Global’s donor material collection services, requesting development of processes to support collection and production of a cGMP cord product.
Dr. Rachel Beddard, Chief Medical Officer at Biobridge Global, led the development of the process. “This achievement is a perfect example of the cross-collaboration within our organization. South Texas Blood & Tissue, QualTex and GenCure joined efforts to set-up a program to provide umbilical cord tissue collected, tested, and aseptically processed, following GMP standards and compliant with U.S. and international regulatory requirements for further manufacture into advanced therapies.”
“Congratulations to the team that helped design and implement the collection and testing procedures, execute on those procedures to collect, test, and process the cord,” Landon said. “We are still steps away from therapies that will save and enhance lives, but we have built a foundation where none existed before.”
BioBridge Global and its subsidiaries have been collecting birth tissue, including umbilical cords, since 2016 and umbilical cord blood for therapeutic use since 2001. All donors consent to IRB-approved collection protocols authorizing the use of their donation for research, clinical, or commercial applications.
About BioBridge Global:
BioBridge Global (BBG) is a San Antonio, Texas-based 501(c)(3) nonprofit regenerative medicine enterprise that offers diverse services through its subsidiaries – South Texas Blood & Tissue, QualTex Laboratories, GenCure and The Blood & Tissue Center Foundation. BBG provides products and services in blood resource management, cellular therapy, donated umbilical cord blood and human tissue as well as testing of blood, plasma and tissue products for clients in the United States and worldwide. BBG is committed to saving and enhancing lives through the healing power of human cells and tissue. It enables advances in the field of regenerative medicine by providing access to human cells and tissue, testing services and biomanufacturing and clinical trials support. Learn more at BioBridgeGlobal.org.
