Let's start with what the FDA says about two questions regarding the topic of Biologics.
"What is a biological product?
Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.
How do biological products differ from conventional drugs?
In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized. Biological products, including those manufactured by biotechnology, tend to be heat sensitive and susceptible to microbial contamination. Therefore, it is necessary to use aseptic principles from initial manufacturing steps, which is also in contrast to most conventional drugs.
Biological products often represent the cutting-edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available."
That is what the FDA says about the broad topic of biologics.
At Comprehensive Biologics we successfully developed proprietary techniques, improving on previous, and sometimes outdated, industry tissue processing standards. It’s the persistent drive to always find a better way that has given Comprehensive Biologics the ability to achieve the Regenerative Medicine Industry’s ultimate goal: Products that are not only safe and efficacious but also rigorously compliant.
The human umbilical cord and placental derived products’ proprietary tissue manufacturing processes do not alter the original relevant characteristics of the tissue, resulting in a pure, homologous product.
We ensure all of our products will meet or exceed established specifications and undergo independent sterility testing in accordance with standards set forth by the American Association of Tissue Banks (AATB), and FDA requirements. Our products are (HCT/P) compliant under Section 361 of the Public Health Service Act according to 21 CFR Part 1271.10. They are regulated as a human cell and tissue product and are intended for homologous use.Member Profile:
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