FDA Registered, cGMP Compliant Tissue Lab
Bello Bio –
First rate tissue processing that is cGMP and AATB Compliant, research driven with a focus on quality assurance!
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
Bello Bio is cGMP compliant and ISO Certified in both its USA and Pakistan locations. The highest global quality assurance standards are followed, along with the standards of the American Association of Tissue Banks (AATB).
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 DRAP Registered in Pakistan, and follows all Good Tissue Practice (GTP) guidelines. The continuous air quality management, ISO Class 7 cleanrooms, Biosafety Level 2 Cabinets and screened donor tissue ensures consistency with the tissue quality and clinical/research results.
Bello Bio operates under strict compliance with federal regulations. Locations of Bello Bio labs include Scottsdale, Arizona in the USA and Islamabad in Pakistan.
Providing our Partners
the Highest Quality Tissue Allografts Available.
About Bello Bio
- Locations in Scottsdale, Arizona and Islamabad, Pakistan
- Compliant with FDA Current Good Manufacturing Practice (CGMP) and FDA Good Tissue Practice (GTP). In fact, Bello Bio Pakistan is Produced in sterile FDA compliant 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, ISO Certified lab, which then processes the cell allograft for therapeutic or research use.
- Our lab specialists screen the tissue under FDA and AATB standards 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 cGMP compliant and FDA registered laboratory.
Production
Bello Bio applies AATB and 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 distributes directly to licensed healthcare providers and institutions. Products are sent with a Certificate of Analysis and Instructions for Use. For purchasing information, please contact us.
Bello Bio Leadership
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Bello Bio is a multi-national tissue processing lab focused on research, clinical and contract manufacturing of umbilical cord tissue allografts. Our labs in the USA and Pakistan are ISO Certified, cGMP Compliant and fully registered with the FDA and DRAP.
Call today for any of your allograft needs!
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