Stem cells from cord tissue to be used to develop new cellular therapies
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.
Story continues
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 Globals attention when it developed its biomanufacturing service line under GenCure. A number of customers had approached GenCure, knowing about BioBridge Globals 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.
See the article here:
BioBridge Global continues history of innovation with umbilical cord collection and processing under cGMP standards for further manufacture - Yahoo...
- Cardiovascular Glossary A-Z (All) | Texas Heart Institute - January 4th, 2023
- ADC Therapeutics Announces Abstracts to be Presented at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO 2022) - Business Wire - September 25th, 2022
- GVHD in the Context of Stem Cell or Allogeneic Transplant - Cancer Network - August 22nd, 2022
- De-extinction Company Aims to Resurrect the Tasmanian Tiger - Scientific American - August 22nd, 2022
- Dean Kamen on the power of celebrating your own obsoletion - TechCrunch - July 27th, 2022
- Westin and Sehn Carve Out the Role of CAR T-Cell Therapy and Transplant in Primary Refractory DLBCL - OncLive - July 27th, 2022
- Unanticipated findings cast new light on the genetic regulation of different brain tumors - Baylor College of Medicine - July 27th, 2022
- Chaotic response in Uvalde, Parkland shooter faces death penalty, mall shooting leaves 3 dead and jury selection begins in Bannon trial | Hot off the... - July 19th, 2022
- Stem Cells, Abortion, Baby Parts, & the Ukraine - Physicians for Life - June 22nd, 2022
- INVECTYS, MD ANDERSON AND CTMC ANNOUNCE STRATEGIC COLLABORATION FOR CAR T CELL THERAPY DEVELOPMENT - BioSpace - June 22nd, 2022
- Quizartinib Plus Chemotherapy Significantly Improved Overall Survival Compared to Chemotherapy in Patients with Newly Diagnosed FLT3-ITD Positive... - June 13th, 2022
- Texas Family Fights to Access $2.1 Million Treatment for Baby - NBC 5 Dallas-Fort Worth - May 15th, 2022
- La Conner native raising funds to cure blood cancer - La Conner Weekly News - May 2nd, 2022
- CORRECTING and REPLACING -- Affimed NV - GlobeNewswire - May 2nd, 2022
- StudyFinds Blotter: Other Notable Health Research From April 28, 2022 - Study Finds - May 2nd, 2022
- Sung to lead cancer institute; Bankston wins fellowship - ASBMB Today - April 19th, 2022
- Houston teen first in Texas to become own donor to reverse sickle cell anemia - FOX 26 Houston - March 25th, 2022
- Oleic Acid, a Key to Activating the Brains Fountain of Youth - Neuroscience News - March 25th, 2022
- Stem Cell Therapy Boosts Outcomes for Some Heart Failure Patients - HealthDay - November 22nd, 2021
- Quizartinib Added to Chemotherapy Demonstrates Superior Overall Survival Compared to Chemotherapy Alone in Adult Patients with Newly Diagnosed... - November 22nd, 2021
- Immatics to Present Update on Lead ACTengine Program IMA203 Targeting PRAME at the Society for Immunotherapy of Cancers 36th Annual Meeting - Yahoo... - November 8th, 2021
- Affimed Announces Poster Presentations at the 63rd American Society of Hematology Annual ... - Tyler Morning Telegraph - November 8th, 2021
- ADC Therapeutics Announces Abstracts to be Presented at the 63rd ASH Annual Meeting - StreetInsider.com - November 8th, 2021
- The Power of the Immune System: New Treatment for Painful Blood Cancer Side Effect - Curetoday.com - October 28th, 2021
- Durham firm offering up to $10,000 for researchers to use its intestinal technology - WRAL Tech Wire - October 16th, 2021
- Elevated cryptic transcription emerges as a common theme in aging mammalian cells - Baylor College of Medicine News - August 31st, 2021
- Insulin-producing implants are being developed to control Type 1 diabetes - Health Europa - August 5th, 2021
- Cryptic Transcription in Mammalian Stem Cells Linked to Aging - Technology Networks - August 5th, 2021
- Overview of DLBCL - Targeted Oncology - August 5th, 2021
- The True Crime Junkies and the Curious Case of a Missing Husband - VICE - August 5th, 2021
- FROM THE LABS: Hispanic Heritage Spotlight: Interview with Dr. Nino Rainusso - Baylor College of Medicine News - November 13th, 2020
- UPMC nurse practitioner hailed 'healthcare hero' on live TV - Altoona Mirror - October 31st, 2020
- BrainStrom Cell Therapeutics (NASDAQ:BCLI) Enters Agreement With Catalent (NYSE:CTLT) For Manufacture Of Its NurOwn Cell Therapy - BP Journal - October 31st, 2020
- Dr. Daisy Ayim, Cosmetic Surgeon, ObGyn, Business Owner and Entrepreneur, Is Revolutionizing The Integration Of Women's Health And Cosmetic Care -... - October 31st, 2020
- Five Indian American Researchers Named Among NIH 2020 New Innovator Awardees - India West - October 21st, 2020
- Reliable tumor detection by whole-genome methylation sequencing of cell-free DNA in cerebrospinal fluid of pediatric medulloblastoma - Science... - October 21st, 2020
- Biotechnology could change the cattle industry. Will it succeed? - Salon - September 8th, 2020
- STEM CELLS | VitaDrip IV Therapy | Texas - June 26th, 2020
- New Preclinical Data Demonstrates Immune-Enhancing Effects of Triple I/O Combination Therapy with BeyondSpring's Plinabulin - BioSpace - June 23rd, 2020
- Tau: Why Alzheimer's Worsens Fast in Some, Slowly in Others - Alzforum - June 23rd, 2020
- Scholarly Perspectives on COVID-19, Part 1: This Was Only a Matter of Time - Southern Newsroom - June 23rd, 2020
- Texas Stem Cell Law Opens Door for Controversial Treatments - June 11th, 2020
- Who's to blame? These three scientists are at the heart of the Surgisphere COVID-19 scandal - Science Magazine - June 9th, 2020
- FTC ramps up enforcement with new wave of warning letters - NutraIngredients-usa.com - June 9th, 2020
- UT Student Awarded Prestigious Astronaut Scholarship - UT News | The University of Texas at Austin - June 9th, 2020
- South Sound Community Bands Together To Save Local Lives - southsoundtalk.com - May 7th, 2020
- Pfizer, NYU working on innovative coronavirus vaccine that could be ready by end of summer - NBC News - May 7th, 2020
- How industry hopes to take on COVID-19 - Bioprocess Insider - BioProcess Insider - March 8th, 2020
- Meng Hsieh, Andrew Shubin - The New York Times - March 8th, 2020
- Jimbo Fisher's Kidz1stFund, Aggie Corps of Cadets team up for Be the Match bone marrow donor registry drive - Bryan-College Station Eagle - March 2nd, 2020
- Texas A&M Researcher Named To National List Of Inspiring Black Scientists - Texas A&M University - March 2nd, 2020
- What to do in Madison: March 2-8, 2020 - The Bozho - March 2nd, 2020
- Cumberland County family turns to non-FDA approved stem cell treatment to help two-year-old son with cerebral palsy - FOX43.com - February 27th, 2020
- Recombinetics Announces Collaboration with University of Texas Southwestern to Advance Regenerative Medicine Through Therapeutic Cell, Tissue, and... - February 27th, 2020
- Stem Cell Therapy for Joints & Spine in Austin Texas - January 28th, 2020
- El Paso scientists to deliver 3D bioprinted miniature hearts to the ISS - 3D Printing Industry - January 28th, 2020
- El Paso scientists team up for heart research project at the International Space Station - KVIA El Paso - January 28th, 2020
- Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020 - JD Supra - December 18th, 2019
- Incoming Faculty Bring New Areas of Research to Rensselaer - Rensselaer Polytechnic Institute - September 24th, 2019
- Nivolumab as an addition to frontline therapy of AML in younger patients - AML Global Portal - September 24th, 2019
- Interview: BIOLIFE4D is The First US Company to Bioprint a Mini-Heart (for Cardiotoxicity Testing) - 3DPrint.com - September 24th, 2019
- Stem cells regrow leg's long bones - WNDU-TV - September 22nd, 2019
- A breakthrough in the battle against citrus greening - Gainesville Sun - September 22nd, 2019
- Comparing Mymetics (OTCMKTS:MYMX) & Crispr Therapeutics (OTCMKTS:CRSP) - TechNewsObserver - September 22nd, 2019
- STEM CELL THERAPY & TREATMENTS Texas Regional Health - September 10th, 2019
- Fast Facts: Stem Cells 101 Vital Record - September 10th, 2019
- Keller, TX Stem Cells | Neuropathy & Pain Centers of Texas - May 31st, 2019
- Arlington Stem Cells | Neuropathy & Pain Centers of Texas - May 1st, 2019
- Houston, Texas Stem Cell Transplants, Richmond, Sugar Land ... - April 21st, 2019
- Fort Worth Stem Cells | Neuropathy and Pain Centers of Texas - April 15th, 2019
- Stem Cell Rejuvenation Therapy | Totalhormonegenetherapy.com - April 15th, 2019
- Our Doctors - Knee Stem Cells - March 17th, 2019
- Stem Cell Treatment Center in Dallas, Texas | Stem Cell ... - March 17th, 2019
- Neuropathy & Pain Centers of Texas - Stem Cells & Neuropathy - February 6th, 2019
- Stem Cell Doctor Dallas Dr. Darcy Brunk | Dallas, Plano ... - January 25th, 2019
- Four Types of Stem Cells - Texas Right to Life - December 15th, 2018
- Texas | The Stem Cellar - December 5th, 2018
- Dallas, Texas, Stem Cells Treatment, Legal, Ft. Worth ... - November 16th, 2018
- HB810 | Right to Try Law | Texas Stem Cell Law | StemGenex - October 13th, 2018
- Shooting Up Stem Cells With Ben Greenfield The Down The ... - September 16th, 2018