Electrospinning biomaterials at Harwell
Cleanrooms
Electrospinning biomaterials at Harwell
Ann Kramer
CEO , ELECTROSPINNING COMPANY
The Electrospinning Company operates out of managed cleanroom facilities at the Rutherford Appleton Laboratory , Harwell Campus . The company designs and manufactures advanced materials for use in regenerative medical devices , stem cell production bioreactors as well as laboratory cell research
The Electrospinning Company was established by STFC ( Science and Technologies Facility Council ) in 2010 to exploit their micro / nano- technology platform in biomedical applications .
The electrospinning technique is used to form nanofibre ‘ scaffolds ’, or matrices , which resemble the architecture of extracellular matrix ( ECM ), the body ’ s natural scaffolding , and thus make excellent environments for growing cells .
Initially the company developed the Mimetix range of products for use in 3D cell culture laboratory research . Cells grown in 3D are more representative of cells in the body that those grown in conventional , flat conditions and therefore can provide more physiologically relevant data to drug developers . Current laboratory experiments are not sufficiently predictive of the in vivo performance of drug candidates , as demonstrated by the high rate of failure of such candidates in animal and human clinical trials .
The cost of discovering and developing a drug is estimated to be $ 0.4 billion , but rises to $ 1.8 billion if the cost of the attrition of candidates is included . There remains a huge unmet need for more predictive laboratory tests , which primary and stem cells grown in 3D environments could deliver .
With Innovate UK support , the company has developed a range of laboratory tools suitable for higher throughput 3D assays targeted at pharmaceutical companies . An example is an aligned fibre model in which oligodendrocyte cells , found
A confocal image of cells in Mimetix scaffold
Chief Executive of the Electrospinning Company , Ann Kramer , in the laboratory
in the central nervous system , which comprises the brain and spinal cord , will form myelin sheaths around synthetic fibres . Demyelination is the loss of the myelin sheath insulating the nerves , and is the hallmark of some neurodegenerative autoimmune diseases including multiple sclerosis .
The greatest value for electrospun materials is in the rapidly emerging field of regenerative medicine , where they can be implanted to promote the repair or regeneration of damaged organs by the patient ’ s own cells .
The Electrospinning Company is establishing a Centre of Excellence in the fabrication of electrospun biomaterials for clinical use . It moved into managed ISO Class V cleanroom facilities in summer 2014 and achieved ISO 13485 medical device quality certification in March 2015 , which are regulatory requirements for production for human implantation .
The company is building expertise with a range of FDA-approved polymers and architectures for different applications . Materials can be designed to promote healing without scarring and then degrade into harmless chemicals that the body can clear . The company offers this capability as a service to medical device companies and universities in the form of feasibility studies , regulatory advice and biomaterial for inclusion in medical devices . The company further develops its capabilities and intellectual property
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