Regenerative Medicine Research and Development Support

Regenerative medicine research is a rapidly growing interdisciplinary field that applies the principles of engineering and life sciences to develop biological tissue substitutes with the aim of improving tissue reconstruction.

Regenerative therapies, including tissue scaffolds that facilitate tissue re-growth, small molecule or biologic drugs, nanoscience, and cell-based therapies such as stem cells, hold great potential for treating life-threatening diseases or injuries, including wound care, dental, dermal, and orthopedic applications.

Developing these complex regenerative medicine products is challenging and requires specialized knowledge in the technologies and applications of this field to accelerate the development process through critical stages of approval and manufacturing.

Our regenerative medicine product analysis and development support services are offered from locations in the USA and Europe to assist with product development, regulatory submission requirements, or manufacturing quality control. Our expertise spans applications for skin, bone, adipose, cartilage, and blood disorders, including work on wound care, dermal fillers, dental and bone grafts, 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. 

Bioanalysis Services 

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.

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, residual solvents, elemental impurity analysis and cGMP batch release testing.

Our biopharmaceutical team provide comprehensive characterisation and potency testing of recombinant hormones such as erythropoietin or recombinant human bone morphogenetic protein products. 

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.