Bello WJ
Bello WJ
BelloWJTM is a cryopreserved, viable cellular allograft containing umbilical cord Wharton’s Jelly tissue. It is designed for homologous use by qualified healthcare professionals.
Description
BelloWJ is a cryopreserved, viable cellular allograft containing umbilical cord Wharton’s Jelly tissue. It is designed for homologous use by qualified healthcare professionals.
Bello Bio uses cord from donors that have either vaginal or c-section procedures. BelloWJ undergoes aseptic processing at a lab that follows to cGMP standards. Once the processing is completed, the tissue is cryopreserved without terminal sterilization using DMSO to protect cellular integrity.
During tissue processing and packaging the allograft is tested and released from quarantine if it shows no evidence of microbial growth, complying with the requirements of USP <71> Sterility Tests.
BelloWJ is compliant with the USA FDA’s classification as a minimal manipulation HCT/P (Human Cellular and Tissue Product) per Section 361 of the Public Health Service Act (PHSA). No culturing is performed on the tissue, and the tissue maintains its original relevant characteristics relating to the tissue’s utility for reconstruction, repair, or replacement.
The HCT/P is not combined with another article except for saline and an approved cryopreservative. In addition, the HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function. BelloWJTM is intended to be administered locally at the site of the tissue defect, and does not have a systemic effect.
Along with qualifying as a minimal manipulation tissue product, BelloWJ is indicated for homologous use including the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor (per FDA Section 21 CFR 1271.3(c).
The function for BelloWJ is consistent with the FDA’s stated umbilical cord function as a “conduit”.
BelloWJ is available in two size vials, either 1cc or 2cc.
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FAQ
GMP stands for Good Manufacturing Practice, which is a set of regulations, rules, and guidelines published by all healthcare authorities. Examples of these healthcare authorities include:
- US Food and Drug Administration (FDA)
- World Health Organization (WHO)
- European Union (in the EUDRALEX)
- UK Medicines & Healthcare Regulatory Agency (MHRA)
GMP regulations provide us with a system that should ensure consistent, controlled products and services. Good implementation of the regulation requirements and guidelines helps us provide the best and safest services and products. These GMP guidelines include all aspects of the product’s life cycle and manufacturing process, from product development and raw materials selection to the final production process, testing, storage, and shipment.
The “c” stands for “current” as a reminder that systems, processes and technologies must be kept up to date to comply with the latest regulations. "
It is important to understand that the FDA does not “approve” or certify health care facilities, laboratories, or manufacturers as GMP. The FDA inspects product manufacturers to verify that they comply with good manufacturing practices but does not issue GMP certificates.
Birth tissue refers to the “products of conception” that are typically discarded as medical waste after a birth. This may include the placenta, amniotic fluid, umbilical cord tissue and umbilical cord blood.
Of note, Bello Bio USA obtains birth tissue from an accredited tissue recovery agency in the USA. This agency screens consenting donors rigorously to make sure they are acceptable with the lowest risk factors possible.
Bello Bio Pakistan maintains its own birth tissue recovery program. As Bello Bio is located within Pak-American Hospital (PAH), mothers undergoing scheduled c-sections at the hospital may consent to donate their birth tissue.
Bello Bio performs rigorous donor screening both on the mother as well as the tissue itself. The tissue testing is consistent with the regulations put forth by the FDA.
The United States FDA has put forth the term Minimal Manipulation referring to tissue products where the processing of the HCT/P does not alter the original relevant characteristics of the tissue relating to the tissue's utility for reconstruction, repair, or replacement.
HCT/P refers to human cells, tissues, and cellular and tissue-based products. Here is how the FDA regulations read (word for word).
The FDA defines minimal manipulation as:
- For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement;
- For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.
The products manufactured at Bello Bio USA or Pakistan are only available for purchase by licensed healthcare professionals. Bello Bio places a current license on file for each customer.
Bello Bio employs several molecular biologists. These individuals are key to the successful production of the clinical and research biologics in both the USA and Pakistan. In order to become a molecular biologist, individuals must study for several years at an institution of higher learning. Once they complete all of the rigorous course load to master the technology necessary for working in the field, they must put forth a strong dissertation and successfully defend it to a faculty committee.
The process of obtaining a PhD as a Molecular Biologist generally takes 4 to 6 years. Drs. Khan and Minter-Dykhouse both obtained their PhD from highly respectable institutions, are well published and have devoted their lives to producing and researching first rate cellular therapy products.
Molecular biologists play a vital role in advancing our understanding of genetics, cell biology, and biochemistry. Their research is used in a variety of fields, including medicine, agriculture, biotechnology, and environmental science. Molecular biologists may work in academic settings, government agencies, or private industry, where they conduct research, develop new technologies, and analyze data to solve complex biological problems.
“Bello” is an Italian word meaning beautiful. “Bio” is short for biologics which means the study of life. Together, Bello Bio means the Beautiful Study of Life!
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