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Design & Development & Testing of Biomaterials
WHAT ARE BIOMATERIALS ?
Biomaterials are any materials, natural or man-made, that comprise whole or part of a living structure or biomedical device which perform, augment, or replace a natural function. Biomaterials are nonviable materials used in medical devices, so they are intended to interact with a biological system. These materials are adapted for medical applications. Biomaterials may have a benign function, such as being used for a heart valve. Biomaterials are also used in dental applications, surgery, and drug delivery (a construct with impregnated pharmaceutical products can be placed into the body, which permits the prolonged release of a drug over an extended period of time). Biomaterials are not only restricted to man-made materials constructed of metals or ceramics. A biomaterial may also be an autograft, allograft or xenograft used as a transplant material.
Some applications of biomaterials are:
Bone plates, Joint replacements, Bone cement
Artificial ligaments & tendons
Some dental implants
Blood vessel prostheses
Skin repair devices
Biomaterials must be compatible with the body, and there are often issues of biocompatibility. Such incompatibility issues need to be resolved before a product can be placed on the market. There are stringent regulatory requirements for biomaterials. Manufacturing companies working with biomaterials are also required to ensure traceability of all of their products so that if a defective product is discovered, others in the same batch can be quickly traced.
Biocompatibility of biomaterials in various environments under various chemical and physical conditions is necessary. Biocompatibility may refer to specific properties of a material without specifying where or how the material is to be used. As an example, a material may elicit little or no immune response in a given organism, and may or may not be able to integrate with a particular cell type or tissue. Medical devices and prostheses are often made of multiple materials, therefore it might not always be sufficient to talk about the biocompatibility of a specific material.
Also, a material should not be toxic unless specifically engineered to be so. An example is smart drug delivery systems that target cancer cells and destroy them. A thorough understanding of the anatomy and physiology of the action site is essential for a biomaterial to be effective. It is therefore important, during design, to ensure that the implement will complement and have a beneficial effect with the specific anatomical area of action.
Biopolymers are produced from living organisms. Cellulose and starch, proteins, peptides, and DNA and RNA are examples of biopolymers, in which the monomeric units, respectively, are sugars, amino acids, and nucleotides. Cellulose is both the most common biopolymer and the most common organic compound on Earth. Some biopolymers are biodegradable. That is, they are broken down into CO2 and water by microorganisms. Some of these biodegradable biopolymers are compostable, they can be put into an industrial composting process and will break down by 90% within 6 months. Biopolymers that do this can be marked with a “compostable” symbol. Packaging marked with this symbol can be put into industrial composting processes to break down within 6 months or less. An example of a compostable polymer is PLA film under certain thickness. PLA films which are thicker than that do not qualify as compostable, even though they are biodegradable. Home composting can enable consumers to dispose of packaging directly onto their own compost heap.
We offer biomaterials design, development, analysis and testing services supporting development and market approval for medical devices and drug device combinations, consulting, expert witness and litigation services.
Design & Development of Biomaterials
Our biomaterials design and development engineers and scientists have expertise in design and manufacturing biomaterials for large IVD manufacturers with proven results in diagnostic kits. Biological tissues are intrinsically organized at multiple scales, they perform multiple structural and physiological functions. Biomaterials are used to substitute the biological tissues and they should therefore be designed in the same way. Our subject experts have the knowledge and know-how in the many scientific facets of these complex materials and applications including biology, physiology, mechanics, numerical simulation, physical chemistry...etc. Their close relationships and experience with clinical research and an easy access to many characterization and visualization techniques are our valuable assets.
One major design area, “Biointerfaces” are critical to the control of the cell response to biomaterials. Biochemical and physico-chemical properties of biointerfaces regulate cell adhesion to biomaterials and uptake of nanoparticles. Polymer brushes, polymer chains attached at one end only to an underlying substrate are coatings to control such biointerfaces. These coatings allow tailoring the physico-chemical properties of biointerfaces via the control of their thickness, chain density and the chemistry of their constitutive repeat units and can be applied to metals, ceramics and polymers. In other words, they allow the tuning of bioactive properties of a wide range of materials, irrespective of their bulk and surface chemistry. Our biomaterial engineers have studied protein adhesion and interaction to polymer brushes, they have investigated the biofunctional properties of the biomolecules coupled to polymer brushes. Their in-depth studies have been useful in the design of coatings for implants, in vitro cell culture systems and for the design of gene delivery vectors.
Controlled geometry is an inherent feature of tissues and organs in vivo. The geometrical structure of cells and tissues at multiple length scales is essential to their role and function, and a hallmark of diseases such as cancer as well. In vitro, where cells are culture on experimental plastic dishes, this control of geometry is typically lost. Reconstructing and controlling some of the geometrical features of biological systems in vitro is important in the development of tissue engineering scaffolds and the design of cell based assays. It will allow a better control of cell phenotype, higher degree structure and function, which are essential for tissue repair. This will allow more accurate quantification of cell and organoid behaviour in vitro and determination of the efficacy of drugs and treatments. Our biomaterials engineers have developed the use of patterning tools at different length scales. These patterning techniques have to be fully compatible with the chemistry of the biomaterials on which these platforms are based, as well as the relevant cell culture conditions.
There are many more design and development issues that our biomaterials engineers have worked on throughout their careers. If you would like specific information regarding a particular product please contact us.
Biomaterials Testing Services
To design, develop and manufacture safe and effective biomaterial products, while meeting the regulatory requirements of marketing authorization, robust laboratory testing is required in order to understand aspects related to product safety, such as the tendency of biomaterial products for releasing leachable substances, or performance criteria, such as mechanical properties. We have access to a wide range of analytical capabilities in order to understand the identity, purity, and biosafety of a growing number of biomaterials utilized in medical products through physical, chemical, mechanical, and microbiological testing methodologies. As part of our work we help manufacturers assess the safety of finished devices with supporting toxicological consulting. We provide analytical services to support product development and quality control of raw materials and finished products. We have experience with many types of biomaterials such as liquids, gels, polymers, metals, ceramics, hydroxyapatite, composites, as well as biologically sourced materials such as collagen, chitosan, peptide matrices, and alginates. Some major tests we can conduct are:
Chemical characterization and elemental analysis of biomaterials to achieve a comprehensive understanding of the product for regulatory submission and for the identification or quantification of contaminants or degradation products. We have access to labs that are equipped with a wide range of techniques to determine chemical composition, such as infrared spectroscopy (FTIR, ATR-FTIR) analysis, nuclear magnetic resonance (NMR), size exclusion chromatography (SEC) and inductively-coupled plasma spectroscopy (ICP) to identify and quantify composition and trace elements. Elemental information about the biomaterial surface is obtained by SEM / EDX, and for bulk materials by ICP. These techniques can also highlight the presence of potentially toxic metals such as lead, mercury and arsenic inside and on biomaterials.
Impurity characterization using laboratory-scale isolation and a range of chromatography or mass spectrometry methods such as MALDI-MS, LC-MSMS, HPLC, SDS-PAGE, IR, NMR and fluorescence…etc.
Biomaterial polymer analysis to characterize the bulk polymer material as well as determine the additive species such as plasticizers, colorants, anti-oxidants and fillers, impurities such as unreacted monomers and oligomers.
Determination of biological species of interest such as DNA, Glycoaminoglycans, total protein content…etc.
Analysis of actives incorporated into biomaterials. We conduct analytical studies to define the controlled release of these active molecules such as antibiotics, antimicrobials, synthetic polymers and inorganic species from the biomaterials.
We conduct studies for the identification and quantification of extractable and leachable substances that arise from biomaterials.
GCP and GLP bioanalytical services supporting all phases of drug development and non-GLP rapid discovery phase bioanalysis
Elemental analysis and trace metals testing to support pharmaceutical development and GMP manufacturing
GMP stability studies and ICH storage
Physical and morphological testing and characterization of biomaterials such as pore size, pore geometry and pore size distribution, interconnectivity, and porosity. Techniques such as light microscopy, scanning electron microscopy (SEM), surface areas determination by BET are used to characterize such properties. X-Ray diffraction (XRD) techniques are used to study the degree of crystallinity and phase types in materials.
Mechanical and thermal testing and characterization of biomaterials including tensile tests, stress-strain and failure flex fatigue testing over time, characterization of viscoelastic (dynamic mechanical) properties and studies to monitor the decay of properties during degradation.
Medical device materials failure analysis, determination of root cause
We can help you meet health, environmental and regulatory requirements, build safety and quality into the design process and product, and streamline manufacturing processes. Our biomaterials engineers have expertise in design, testing, standards, supply chain management, technology, regulatory compliance, toxicology, project management, performance improvement, safety and quality assurance. Our consulting engineers can halt issues before they become problems, help to manage and assess risks and hazards, provide innovative solutions to complex issues, suggest design alternatives, improve processes and develop best procedures for optimizing efficiency.
Expert Witness and Litigation Services
AGS-Engineering biomaterials engineers and scientists have experience in providing testing for patent and product liability legal actions. They have written Rule 26 expert reports, assisted in claim construction, testified in deposition and trial in cases involving polymers, materials, and medical devices related to both patent and product liability cases.
For help with the design, development and testing of biomaterials, consulting, expert witness and litigation services contact us today and our biomaterials researchers will be glad to help you.
Our FDA and CE approved medical products can be found on our medical products, consumables and equipment site http://www.agsmedical.com