Amnio Technology: Advancing the Science of Regenerative Medicine
Larry Macal, Director of Operations
Toward the end of the 20th century, scientists discovered the therapeutic value of the amniotic tissue, and since then, its expanded use and applications, specifically for wound care, have taken phenomenal strides. However, there are numerous potential applications that are yet to be demonstrated in clinical settings. Headquartered in Phoenix, AZ, Amnio Technology is a global leader in the development and distribution of amniotic tissue allografts. This company is introducing several unmet potential applications of amniotic allografts to the industry and is investing in creating products with pharma-compliant quality. As newer regulations rollout, Amnio will be in a better position to demonstrate not only from a “performance in the market” perspective but also from a regulatory standpoint.
Amniotic tissues are composed of elements that are essential for fetal growth and development, such as extracellular matrix proteins, growth factors, cytokines, carbohydrates, and hyaluronic acid, to name a few. By making considerable advancements in the use of these unique allografts, Amnio Technology is improving the quality of life for patients in need of better wound care. Explaining how Amnio Technology is achieving this, Larry Macal, Director of Operations, Amnio Technology, says, “We have invested heavily in upgrading our contract manufacturing facility and processes, bringing in a level of automation at appropriate places.” Amnio Technology focuses on a combination of technical and supply chain parameters and evaluates ways to rapidly bring the tissue from manufacturing, through in-process and post-process monitoring, all the way through to cryogenic storage. Through their formulation procedure and most importantly, the reduced time that is taken for processing the product, the shelf life and efficacy is enhanced.
Being agile has allowed us to align our investments toward improving the contract manufacturing facility, supply chain and quality, and ensure our workflow is in alignment with the FDA’s requisites
However, when it comes to selecting the right amniotic tissue product for wound care, there arises a dilemma. The amniotic membrane is composed of two distinct layers that surround the embryo: the amnion that lines the inner surface of the amniotic sac interfacing with the foetus, and the chorion that is the outer layer in contact with the maternal tissue. While the chorion is easier to extract, it is thicker and difficult to absorb. Amnio Technology has differentiated itself by succeeding in extracting only the amnion layer for therapeutic purposes through proven technologies.
Meanwhile, from a regulatory perspective, Amnio Technology is well poised to meet the FDA standards of Biologics Licence Application. More so, for any membrane product manufacturer, the transition from a biological environment to a pharmaceutical one is challenging, given the requirements to demonstrate clinical trials and clinical results. However, Amnio Technology has already testified its capabilities through product formulations and accelerated manufacturing processes, and the firm is prepared to enter the pharmaceutical environment. “Being agile has allowed us to align our investments toward improving the contract manufacturing facility, supply chain and quality, and ensure our workflow is in alignment with the FDA’s requisites,” adds Macal.
The transition to a pharmaceutical environment is driving and opening newer markets for amniotic membrane allografts. For its part, Amnio Technology is already keen on expanding its capabilities to meet future regulations of the FDA with their exceptional know-how of the domain and zeal to invest for the greater good.
Description Amnio Technology enhances the gift of human birth tissue donation by developing, processing and distributing innovative allografts that provide regenerative therapies to improve quality of life. Amnio Technology is committed to advancing the science of regenerative medicine by developing and introducing new amniotic tissue allografts and technologies to treat patients in need
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