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

BelloWJTM is a cryopreserved, viable cellular allograft containing umbilical cord Wharton’s Jelly tissue. It is designed for homologous use by qualified healthcare professionals.

 

The Wharton’s Jelly umbilical cord tissue is recovered from a consenting donor after a scheduled c-section, with no harm to either baby or mother. BelloWJTM undergoes aseptic processing at an ISO Certified lab that adheres to both cGMP and AATB 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 only passes quarantine if it shows no evidence of microbial growth, complying with the requirements of USP <71> Sterility Tests.

BelloWJTM 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, BelloWJTM 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 BelloWJTM is consistent with the FDA’s stated umbilical cord function as a “conduit”.

 

BelloWJTM 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)
  • Drug Regulatory Authority of Pakistan (DRAP)

 

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 and recommended by AATB.

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.

ISO certification is a credential that validates a business's fulfillment of requirements relating to quality process standards as defined by the International Standards Organization (ISO). The ISO is a non-governmental organization that determines specifications for products, services and systems for quality and efficiency.

Because it’s an International requirement, it’s one way for businesses to comply with regulations that are deemed acceptable around the world. In fact, ISO has standards in over 150 countries for all types of agriculture, food safety, health care, manufacturing, risk management, technology and occupational health/safety.

Bello Bio achieved ISO Certification in both USA and Pakistan as a Cleanroom meeting ISO 7 Standards for acceptable particle counts.

Obtained from third parties, ISO certifications function as proof that a business abides by the standards set forth by the ISO. As such, they help to instill confidence in clients and other interested parties that the business conducts itself efficiently and strives for high quality.

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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