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!