Regenerative Medicine Analysis and Development Support
Regenerative medicine product analysis services for tissue scaffolds, drugs, nano- and cell-based therapies supporting research, regulatory and manufacturing
Regenerative medicine is a rapidly growing interdisciplinary field, which applies the principles of engineering and life sciences to develop biological tissue substitutes with the aim of improving tissue reconstruction.
Regenerative therapies such as tissue scaffolds that facilitate tissue re-growth, small molecule or biologic drugs, nanoscience and cell-based therapies such as stem cells. These advanced therapeutic approaches have great potential to treat life-threatening diseases or injuries including wound care treatment, dental, dermal or orthopaedic applications.
Development of these complex regenerative medicine products is challenging and requires specialised knowledge in the technologies and applications of this field in order to accelerate the development process through the critical stages of approval and manufacturing.
Our regenerative medicine product analysis and development support services encompass services from locations in the USA and Europe to support your product development, regulatory submission requirements or manufacturing quality control. Our experience spans applications for skin, bone, adipose, cartilage and blood disorders and our work includes wound care, dermal fillers, dental, bone graft and other tissue scaffolds, biomaterials, biological regenerative drugs, medical device support, stem cell technologies and analytical support for bioprocessing.
Acellular Tissue Scaffold Services
Our biomaterials scientists draw upon a wide range of analytical capabilities in order to understand the identity, purity, impurities and biosafety of a growing number of biomaterials utilised in tissue acellular scaffold products through physical, chemical and mechanical testing programs for raw materials or finished products. We can determine impurities such as trace metals or leachable substances and scaffold processing residuals such as detergent or antibiotics. We have experience across many types of biomaterials such as hydroxyapatite, composites or biologically sourced material such as collagen, extracellular matrix, chitosan, peptide matrices and alginates.
Supporting preclinical and clinical safety and efficacy assessment of regenerative medicine products, our bioanalysis capabilities include method development, validation, method transfer, high throughput sample analysis and pharmacokinetic and toxicokinetic support, combined with automated data capture and reporting system.
Our dedicated biomarker assay team apply and validate a range of biomarker assays for multiple matrices, for use in Good Laboratory Practice (GLP) compliant preclinical and clinical development programs.
Electron Microscopy (TEM) is particularly useful regarding image tissue and cell samples analysis and can be provided to support GLP programs.
Regenerative Drugs Analysis and Development Support
We also provide regulatory appropriate CMC laboratory services including method development and validation, analysis, stability studies, extractables and leachables, cGMP quality control testing, residual solvents, elemental impurity analysis and cGMP batch release testing.
Cell-Based Therapies Services
Supporting GMP cell bioprocessing, Intertek’s teams provide method development and validation for cell culture media analysis and process residuals analysis. Our biotechnology teams are adept in the analysis of substances from cell secretions and studying the interaction of cells with substrates.
Our regenerative medicine interdisciplinary team includes cell biologists, biomaterial scientists, analysts and pharmaceutical development experts. Bringing quality and safety to life, we apply our vast knowledge of engineering and life sciences to accelerate your regenerative medicine product development. Intertek Total Quality Assurance expertise is delivered consistently with precision, pace and passion, helping to ensure that your products meet safety, efficacy, quality standards and regulatory requirements.
- Management System Certification
- Notified Body Reviews for the Medical Device Directive
- FDA 510(k) Third Party Reviews