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      Biocompatibility of polymer-based biomaterials and medical devices – regulations,in vitroscreening and risk-management

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          Abstract

          Biomaterials play an increasing role in modern health care systems.

          Abstract

          Biomaterials play an increasing role in modern health care systems. Biocompatibility poses a significant challenge for manufacturers of medical devices and contemporary intelligent drug delivery technologies from materials development to market approval. Despite a highly regulated environment, biocompatibility evaluation of biomaterials for medical devices is a complex task related to various factors that include mainly chemical nature and physical properties of the material, the contact tissue and duration of contact. Although international standards, such as ISO 10993-1, are generally employed to prove regulatory compliance needed for market clearance or for initiating clinical investigations, they may not offer sufficient guidance, or risk-management perspective when it comes to choosing materials or appropriate in vitrobiocompatibility screening methods when developing medical devices. The global normative approach towards the biocompatibility evaluation of medical devices is presented in this review, with a focus on in vitrostudies. Indeed, a risk-management approach towards the judicial choice of in vitrotests throughout the development and production of medical devices and drug delivery systems will facilitate rapid regulatory approval, avoid unnecessary animal studies, and ultimately reduce risks for patients. A detailed overview towards the construction of a comprehensive biological evaluation plan is described herein, with a focus on polymer-based materials used in medical applications. Polymeric materials offer a broad spectrum of applications in the manufacturing of medical devices. They are extensively employed within both conventional and innovative drug delivery systems with superior attributes supporting robust, extended use capacity, capable of meeting specific requirement such as adhesion, drug release, and more. Various methods of biocompatibility assessment are detailed within, with an emphasis on scientific analysis. This review may be of interest to those involved in the design, manufacturing and in vitrotesting of medical devices and innovative drug delivery technologies, specifically with respect to a risk-management approach towards the biocompatibility assessment of polymer-based devices.

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          Most cited references 113

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          On the mechanisms of biocompatibility.

          The manner in which a mutually acceptable co-existence of biomaterials and tissues is developed and sustained has been the focus of attention in biomaterials science for many years, and forms the foundation of the subject of biocompatibility. There are many ways in which materials and tissues can be brought into contact such that this co-existence may be compromised, and the search for biomaterials that are able to provide for the best performance in devices has been based upon the understanding of all the interactions within biocompatibility phenomena. Our understanding of the mechanisms of biocompatibility has been restricted whilst the focus of attention has been long-term implantable devices. In this paper, over 50 years of experience with such devices is analysed and it is shown that, in the vast majority of circumstances, the sole requirement for biocompatibility in a medical device intended for long-term contact with the tissues of the human body is that the material shall do no harm to those tissues, achieved through chemical and biological inertness. Rarely has an attempt to introduce biological activity into a biomaterial been clinically successful in these applications. This essay then turns its attention to the use of biomaterials in tissue engineering, sophisticated cell, drug and gene delivery systems and applications in biotechnology, and shows that here the need for specific and direct interactions between biomaterials and tissue components has become necessary, and with this a new paradigm for biocompatibility has emerged. It is believed that once the need for this change is recognised, so our understanding of the mechanisms of biocompatibility will markedly improve.
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            Mediation of biomaterial-cell interactions by adsorbed proteins: a review.

            An appropriate cellular response to implanted surfaces is essential for tissue regeneration and integration. It is well described that implanted materials are immediately coated with proteins from blood and interstitial fluids, and it is through this adsorbed layer that cells sense foreign surfaces. Hence, it is the adsorbed proteins, rather than the surface itself, to which cells initially respond. Diverse studies using a range of materials have demonstrated the pivotal role of extracellular adhesion proteins--fibronectin and vitronectin in particular--in cell adhesion, morphology, and migration. These events underlie the subsequent responses required for tissue repair, with the nature of cell surface interactions contributing to survival, growth, and differentiation. The pattern in which adhesion proteins and other bioactive molecules adsorb thus elicits cellular reactions specific to the underlying physicochemical properties of the material. Accordingly, in vitro studies generally demonstrate favorable cell responses to charged, hydrophilic surfaces, corresponding to superior adsorption and bioactivity of adhesion proteins. This review illustrates the mediation of cell responses to biomaterials by adsorbed proteins, in the context of osteoblasts and selected materials used in orthopedic implants and bone tissue engineering. It is recognized, however, that the periimplant environment in vivo will differ substantially from the cell-biomaterial interface in vitro. Hence, one of the key issues yet to be resolved is that of the interface composition actually encountered by osteoblasts within the sequence of inflammation and bone regeneration.
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              Interpretation of protein adsorption: surface-induced conformational changes.

               C Perry,  D Farrar,  Paul Roach (2005)
              Protein adhesion plays a major role in determining the biocompatibility of materials. The first stage of implant integration is the adhesion of protein followed by cell attachment. Surface modification of implants (surface chemistry and topography) to induce and control protein and cell adhesion is currently of great interest. This communication presents data on protein adsorption (bovine serum albumin and fibrinogen) onto model hydrophobic (CH(3)) and hydrophilic (OH) surfaces, investigated using a quartz crystal microbalance (QCM) and grazing angle infrared spectroscopy. Our data suggest that albumin undergoes adsorption via a single step whereas fibrinogen adsorption is a more complex, multistage process. Albumin has a stronger affinity toward the CH(3) compared to OH terminated surface. In contrast, fibrinogen adheres more rapidly to both surfaces, having a slightly higher affinity toward the hydrophobic surface. Conformational assessment of the adsorbed proteins by grazing angle infrared spectroscopy (GA-FTIR) shows that after an initial 1 h incubation few further time-dependent changes are observed. Both proteins exhibited a less organized secondary structure upon adsorption onto a hydrophobic surface than onto a hydrophilic surface, with the effect observed greatest for albumin. This study demonstrates the ability of simple tailor-made monochemical surfaces to influence binding rates and conformation of bound proteins through protein-surface interactions. Current interest in biocompatible materials has focused on surface modifications to induce rapid healing, both of implants and for wound care products. This effect may also be of significance at the next stage of implant integration, as cell adhesion occurs through the surface protein layer.
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                Author and article information

                Contributors
                (View ORCID Profile)
                (View ORCID Profile)
                Journal
                BSICCH
                Biomaterials Science
                Biomater. Sci.
                Royal Society of Chemistry (RSC)
                2047-4830
                2047-4849
                2018
                2018
                : 6
                : 8
                : 2025-2053
                Affiliations
                [1 ]Paris-Sud University
                [2 ]Faculty of Pharmacy
                [3 ]EA 401
                [4 ]“Groupe Matériaux et Santé”
                [5 ]Paris
                [6 ]Premedical Unit
                [7 ]Weill Cornell Medicine in Qatar
                [8 ]Doha
                [9 ]Qatar
                Article
                10.1039/C8BM00518D
                © 2018
                Product
                Self URI (article page): http://xlink.rsc.org/?DOI=C8BM00518D

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