Under the guidance of clinical and industry experienced experts, Seed Biotech’sTM core competency is based on a novel decellularization and stabilization process which is conducted in a quality by design facility with advanced operational support systems. Seed BiotechTM is uniquely able to optimally prepare highly variable biological materials through a dynamic purification process that depletes biomaterials of cell and cellular contents without imparting unintentional alterations to the extracellular matrix comprised of soluble and non-soluble bioactive constituents. It is this technology that uniquely positions Seed BiotechTM as an industry leader in innovation and a manufacturer of high quality products that professionals in the medical community can have confidence in.
What sets us apart is our Process. We use precise methods to get measurable results and thereby create better biologic products. We have shown a greater than 95% reduction in DNA using our proprietary decellularization process.
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Risks for Transmission from Residual Donor DNA.
There is an inherent time delay between the first presentation and point in time when a communicable disease is regarded as a risk to the general population and when a state of national/global awareness of that communicable disease will exist. Numerous clinical presentations of the disease with symptoms will occur in addition to numerous events of transmission where presentations of symptoms have not been observed. Prior to awareness and further national recognition of the risk, donors could potentially suffer or carry such diseases and therefore even through employment of currently required and exhaustive screening and testing measures, the time factor and state of knowledge limits what can reasonably be anticipated from the effectiveness of such measures.
Challenge of the time delay in disease transmission, awareness, and recognition.
It is likely we will occasionally if not continually have to face the challenge of not having the proper tools to detect diseases in tissue donors even once awareness and recognition, and more importantly the need, occurs. We face this exact challenge currently in association with prion based disease transmission and even with the implementation of best and required practice, we know that our efforts are inadequate to detect if and when donors have disease causing cellular prion proteins. Without any additional options available, there is only one pathway to mitigate theses clinically relevant risks. As such, Seed BiotechTM purifies donated tissue materials depleting them of cell and cellular contents and batch verifies the material as suitable for use. In contrast to current leading manufacturers of human placental tissue products decision to intentionally provide product configurations that retain donor devitalized cells, Seed BiotechTM has established and recognizes the criticality to employing an effective decellularization process to donated human tissues intended for further use as a raw material in clinically used products, and believes there are no other production methods available to achieve a comparable and acceptable safety profile for such products nor a clinical advantage for doing so.1 Seed BiotechTM believes they will continue to be differentiated from competitors that DO employ decellularization production methods because this novel process technology was developed to achieve normalization of a highly variable starting material consistently to a pre-established required state of purity without alteration or loss to the quality of the native extracellular matrix material.
Residual DNA Impacts Performance.
Exacerbated or chronic inflammation and undesirable fibroblast activity are potential additional consequences of implantation of product containing non-self low molecular weight peptides.2,3,4,5 The presence of residual genetic DNA of donor cells in allograft tissues would be anticipated to have an additive effect on normal inflammation occurring as a part of the natural wound healing process. Additionally, it has been shown that the presence of residual DNA is correlated with increased fibroblast activity, which is recognized to be associated with fibrotic tissue formation.
Measurement Metrics of Clinical Benefit Potential.
Seed BiotechTM does not neglect clinically relevant properties regarded to be related to the quality and effectiveness of the end products, in fact our ongoing journey for scientific expertise and understanding of mechanisms of action is the manner to which we acquired knowledge regarding the properties of tissue products that relate to safety. The knowledge regarding the mechanisms of action of tissue products were equally prioritized during the development of the process methods and process and product development approach Seed BiotechTM selected for use for the manufacture of tissue as a raw material. The process used to prepare our products was verified to preserve the surface chemistry, architecture, composition, geometry, and organization of the extracellular matrix (ECM) of the material. Evaluation of paired samples of native and Seed Biotech processed human placental tissue demonstrate the process does not induce alterations to the structure, composition, chemistry and organization of human placental tissue ECM.
Evaluations focused on much more than showing just preservation of the ECM soluble constituents, but more importantly post process preservation of the numerous critical properties of the ECM. Such properties are recognized as critical to cell activity and tissue cascades, including the material interface (surface chemistry and surface morphology), structure, composition, and organization are critical drivers of cell activity.5,6,,7,8,9,10,11 The ECM of connective tissues acts as a reservoir of bioactive peptides including TIMPS, growth factors, cytokines, and glycosaminoglycans and the basement membrane interface acts as a substrate that supports cellular adhesion, transplanar migration, and proliferation. When the ECM origin is a neotenic or juvenile biological connective tissue, such as placental tissue, and effective preparation and preservation occurs, inherent properties unique to neotenic tissues can be used for potential clinical benefit.6,11 Seed BiotechTM innovations are driven by a focus on improving clinical outcomes, specifically reduction in undesirable secondary clinical symptoms common to surgical intervention, such as infection and loss of ROM fibrosis, and improving frequency and extent of quality tissue regeneration vs. fibrotic tissue post-surgery, and vascular tissue injury. Seed BiotechTM further hopes to contribute by working with clinicians in bringing technologies to market which will allow clinicians to address clinical scenarios and conditions that currently remain very challenging because they are without adequate tools suitable to circumstances.
Consistent with our mission to prioritize clinical convenience, clinical practicality, and clinical effectiveness , there were numerous considerations incorporated into the design of our product lines, from the packaging it is stored in, to the shape it is configured in, which all relate to optimizing its suitability for use and potential for clinical benefit but, FIRST AND FOREMOST, our products were developed with design requirements for safety, and products provided are verified to satisfy that requirement.
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(2) Brown BN, Valentin JE, Stewart-Akers AM, McCabe GP, Badylak SF. Macrophage phenotype and remodeling outcomes in response to biologic scaffolds with and without a cellular component. Biomaterials. 2009 Mar;30(8):1482-91.
(3)Keane TJ, Londono R, Turner NJ, Badylak SF. Consequences of ineffective decellularization of biologic scaffolds on the host response. Biomaterials. 2012 Feb;33(6):1771-81.
(4) Vandevord P, Singla A, Krishnamurthy B. The effects of DNA Extracts from Urological Tissue Matrices. Society for Biomaterials. 2006.
(5)Mutsaers SE, Bishop JE, McGrouther G, Laurent GJ. Mechanisms of tissue repair: from wound healing to fibrosis. Int J Biochem Cell Biol. 1997 Jan;29(1):5-17.
(6)Badylak SF. The extracellular matrix as a scaffold for tissue reconstruction. Semin Cell Dev Biol. 2002 Oct;13(5):377-83.
(7)Chun BY, Kim HK, Shin JP. Dried human amniotic membrane does not alleviate inflammation and fibrosis in experimental strabismus surgery. J Ophthalmol. 2013;2013:369126.
(8)Soo-Hyun Kim, Jeremy Turnbull, and Scott Guimond Extracellular matrix and cell signalling: the dynamic cooperation of integrin, proteoglycan and growth factor receptor J Endocrinol 209 139-151, doi: 10.1530/JOE-10-0377 First published online 9 February 2011
(9) Bhatia, Mohit, et al. "The mechanism of cell interaction and response on decellularized human amniotic membrane: implications in wound healing."Wounds 19.8 (2007): 207-217.,
(10)Zhang T, Yam GH, Riau AK, Poh R, Allen JC, Peh GS, Beuerman RW, Tan DT, Mehta JS. The effect of amniotic membrane de-epithelialization method on its biological properties and ability to promote limbal epithelial cell culture. Invest Ophthalmol Vis Sci. 2013 Apr 30;54(4):3072-81
(11) Guo Q, Lu X, Xue Y, Zheng H, Zhao X, Zhao H. A new candidate substrate for cell-matrix adhesion study: the acellular human amniotic matrix. J Biomed Biotechnol. 2012;2012:306083. (13)Stephen Tottey, Scott A. Johnson, Peter M. Crapo, Janet E. Reing, Li Zhang, Hongbin Jiang, Christopher J. Medberry, Brandon Reines, Stephen F. Badylak The effect of source animal age upon extracellular matrix scaffold properties Biomaterials, Volume 32, Issue 1, January 2011, Pages 128-136