FDA registered tissue lab aligned with cGMP guidelines
Bello Bio –
First rate tissue processing guided by cGMP principles, research driven with a focus on quality
VISION & MISSION
Who We Are?
Bello Bio is a first rate tissue allograft lab that processes ethically acquired birth tissue for use in the following settings:
- Clinical Therapies
- Research for clinical trials and basic science
- Cosmetic Use
First rate tissue processing guided by cGMP principles, research driven with a focus on quality
When used in a clinical setting, the birth tissue allografts provide the highest quality tissue to promote safe and predictable results. Bello Bio is FDA Registered in the USA, and follows 1271.150 Current good tissue practice requirements. The continuous air quality management, Biosafety Level 2 Cabinets and screened donor tissue ensures consistency with the tissue quality and clinical/research results, and screened donor tissue ensures consistent, premium quality tissue products.
Bello Bio operates under strict compliance with federal regulations. Bello Bio is located in Scottsdale, Arizona.
Providing our Partners
the Highest Quality Tissue Allografts Available.
About Bello Bio
- Bello Bio is located in Scottsdale, Arizona.
- Compliant with FDA Current Good Manufacturing Practice (cGMP) and FDA Good Tissue Practice (GTP). In fact, Bello Bio is Produced in sterile FDA registered laboratory
- Processed with the highest safety, testing and quality control
- Participating hospitals invite mothers expecting normal, healthy births to donate the resulting umbilical cord. This tissue was once disposed of as waste, but is now considered to be an excellent source of high-quality stem cells and other regenerative elements.
- At the time of birth, a technician enters the delivery room to collect the birth tissues
- With the mother’s informed consent, the umbilical cord is clamped off when the baby is born.
- The tissue is placed in a sterile saline ice bath and transported to our cGMP compliant, which then processes the cell allograft for therapeutic or research use.
- Our lab specialists screen the tissue and process them according to product specific SOPs.
- We ship in single-dose preparations on dry ice for maximum preservation
Consent
The option to donate umbilical cord tissue is offered to expecting mothers by participating hospitals. Mothers who choose to donate undergo a rigorous screening and sign consent forms, indicating they consent to have their umbilical cord tissue used in medicine.
Donation
Umbilical cord tissue and blood extraction is conducted by a qualified individual immediately following delivery. Tissue is then processed in a FDA registered laboratory.
Production
Bello Bio applies FDA regulatory standards to screen umbilical cord tissue for quality, pathogens and disease. We partner with an accredited third party to achieve comprehensive testing/screening.
Sale
Bello Bio only distributes to Regen Suppliers our “exclusive distributor” this also means Bello Bio needs to have an exclusive distribution arrangement” signed with Regen Suppliers. These contracts are required for accreditation.
Contact Regen Suppliers at (888) 568-6909 to get in touch with a representative.
Bello Bio Leadership
Samantha Brechner
President
Michael Clark
Manager of Quality and Regulatory Affairs
Dr. Katherine Minter-Dykhouse
Chief Science Officer
Dr. Sabrina Solt
Medical Director
Gaby Rosales
Operations and Logistics Specialist
Braydon Martinez
Finance and Treasury Coordinator
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