Orthobiologic and bone graft product testing, research and development support undertaken, with regulatory testing and certification services implemented
Orthobiologic and bone graft products are sophisticated, highly pure biomaterials often based on calcium phosphate (hydroxyapatite) composites and other biomaterials which are typically bioengineered to mimic the structure of human bone to optimise bone regeneration. There are three major types of bone grafts: autografts, allografts, and bone substitute. Depending on their properties, preparation and application, bone grafts help bone to regrow via different healing processes such as osteoconduction, where the bone grows on a surface. These products are often used in conjunction with a growth factor or recombinant protein based therapeutic.
Regulatory authorities expect that all risks to health generally associated with the use of the bone graf material devices - such as ineffective bone formation or adverse tissue reaction - are addressed through comprehensive materials characterisation, in vitro studies and stability studies.
Our orthobiologic and bone graft product testing expertise helps clients to accelerate the development process and support the critical stages of approval and certification. We support pre-clinical and clinical trials via bioanalysis in our GLP laboratories which utilize recognised standards or equivalent methods to determine the chemical composition and physical properties of the biomaterials.
Bone graft products chemical composition
Our scientists perform complete chemical composition, including determination of all additives and trace impurities. Our strength in elemental analysis and inorganic material analysis signifies that we have assisted many clients who have developed and attained successful authorisation for materials such as hydroxyapatite, calcium phosphate / synthetic polymer composites, calcium phosphate / collagen composites and other biomaterials / tissue scaffold materials including chitosan, alginates as well as collagen or other protein or peptide matrices.
Using elemental analysis techniques such as ICP-MS, or XRF we can determine the calcium to phosphorous ratio (Ca/P) or trace metal impurities.
Bone graft products physical properties
With a wide range of analytical instrumentation, our laboratories provide an unrivalled range of physical property measurements. Microscopy studies include optical and electron microscopy (SEM or TEM) image acquisition which depict particle size, shape, and porosity. We determine surface area and volumetric porosity (% void space) measurements using the ET technique and dynamic light scattering techniques in order to attain particle size distribution information.
Our physico-chemical property laboratories can also determine water solubility: the pH of the materials and moisture content.
X-ray powder refraction (XRD) enables us to study the phase composition, crystal structure and morphology of bone graft materials in order to determine phase purity, i.e., the relative mass percentages of crystalline and amorphous phases.
Our teams use spectroscopy methods such as infrared (FTIR) and Raman combined with transmission electron microscopy (TEM) to obtain further structural and microstructural information.
In vitro studies
In vitro studies are performed in simulated body fluid (SBF) helps to verify the formation of apatite layer onto surfaces. We perfom such studies – to GLP standard - in order to study the deposition of calcium and phosphorus ions onto surfaces, with microscopy techniques such as SEM used to confirm the formation of bone-like apatite layer on the surface of the bone graft materials.
Stability of bone graft materials
Our stability programs include controlled stability storage and regulatory complaint testing programs (GLP or GMP). Testing programs include weight loss by thermogravimetric analysis, pH, and elemental composition and calcium deposition.
Intertek provides comprehensive material characterisation and physical property determination via a global network of state of the art laboratories.
Bone graft product services
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