Clinical Grade Electrospun Scaffolds
Consistent and compliant production of materials for use in regenerative devices
Electrospun scaffolds can be designed to mimic the extracellular matrix in terms of its architecture, chemical functionality and mechanical properties, therefore providing an ideal substrate for cell growth, differentiation and ultimately tissue repair. However, their use in regenerative medicine has been hindered by the difficulty of consistent production of materials free of residual solvents. The Electrospinning Company provides the highest level of quality for the design, development, analysis and manufacture of electrospun materials in compliance with the European Medical Device Directive 93/42/EEC. Our production is performed to ISO 13485:2003 standards in Class 7 cleanrooms by experienced scientists. We have extensive design and manufacturing capabilities to develop bespoke electrospun scaffolds from a variety of polymers and in custom formats. Our proprietary know-how in manufacturing methods and polymer chemistry enables precise control over important fibre parameters, such as diameter and surface texture, resulting in excellent batch-to-batch reproducibility. We conduct thorough quality control in-house and through relationships with GLP-accredited partners and can provide documentation to support regulatory submissions for clinical trials. Our materials will be in the clinic in India and the USA in 2016. Electrospun materials can be manufactured into implantable medical devices, coatings to improve the acceptance of implants, or supports for implantation of autologous or allogeneic cells for reconstructive therapy. Scaffolds are made from FDA-approved polymers and formulated to degrade over defined periods in vivo. They can be used as carriers for therapeutic compounds, either by incorporation of bioactive compounds into the fibres themselves or by modifying the surface properties.