GMP Electrospinning for Stent Coatings and Bioresorbable Scaffolds

The process of electrospinning has attracted significant attention from many biomedical and pharmaceutical research groups worldwide, owing to its simplicity and flexibility for the fabrication of micron and sub-micron diameter fibrous materials, which possess high surface area and biomimetic structure that closely resembles that of the natural extra-cellular matrix within our tissues. Electrospun materials have been demonstrated to provide benefits in the areas of tissue engineering and regenerative medicine as well as in drug delivery. Since 2016, the first biomedical implants comprising electrospun materials have been FDA approved for commercial clinical use and many more electrospun medical and pharmaceutical devices are in development and clinical trials.

This paper will introduce the technology and present some of the most promising developments in the areas of electrospun stent coatings and bioresorbable vascular grafts and provide consideration to the necessary GMP certification for the manufacturing of such materials, in particular those incorporating active pharmaceutical ingredients e.g. drug eluting stent coatings.

In 2018, Bioinicia became the first electrospinning contract manufacturer to be granted GMP (pharma) certification for the manufacture of drug-loaded electrospun materials for clinical use, easing the pathway for new electrospun drug-delivery devices to enter the clinic.