Biomaterial analysis and testing services supporting development and market approval of tissue scaffold, wound care or implantable medical devices or drug/device combinations
Characterisation and testing of biomaterials are necessary to provide a detailed chemical composition which, when combined with toxicological risk analysis, is necessary to accelerate material or device development and also to identify biological hazards and demonstrate compliance with regulatory expectations.
Biomaterials can be materials of natural origin or made synthetically which can be implanted to replace or repair missing tissue. These have applications in medical devices, drug delivery or combination products, such as regenerative medicine, regenerative dentistry, joint replacements, bone graft, tissue scaffolds, wound care, implantable devices and also in cosmetic surgery.
To support development, data from analysis provides insight into the material’s characteristics and how this is impacted by production processes, microstructure, and chemistry. Understanding structural, surface properties, physical and mechanical properties are important as they impact device performance, stability and safety. To ensure safe and effective biomaterial products, and to meet the regulatory requirements of marketing authorisation, robust laboratory testing is required in order to understand aspects related to product safety, such as their tendency for releasing leachable substances, or performance criteria, such as mechanical properties.
Biomaterials Analysis Expertise
Our biomaterials scientists draw upon a wide range of analytical capabilities in order to understand the identity, purity, and biosafety of a growing number of biomaterials utilised in healthcare products through physical, chemical, mechanical, and microbiological testing methodologies. We have experience with many types of materials used such as liquids, gels, polymers, metals, ceramics, hydroxyapatite, composites, or biomaterials such as collagen, hyaluronic acid, chitosan, peptide matrices, and alginates. We also help manufacturers assess the safety of finished devices with supporting toxicological consulting. We provide analytical programs to support product development and also routine QC of raw materials or finished products.
Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
Biomaterials Analysis Services Include
- Process residuals quantification e.g. antibiotics or surfactants
- Determination of relevant biological species, e.g. DNA, Glycoaminoglycans (GAGs), total protein content
- Bioanalysis to support preclinical and clinical trials
- Elemental Analysis and Trace Metals
- ICH Stability studies
- Mechanical testing (e.g. tensile strength)