06 Feb BIOINICIA IS AWARDED GMP CERTIFICATION FOR ITS INDUSTRIAL MANUFACTURING PLANT FOR ELECTROSPUN NANOFIBERS
Paterna, Spain – February 6th, 2018: Spain-based Bioinicia SL announced the GMP (Good Manufacturing Practices) approval for the production of nanofiber-based drug delivery products.
Bioinicia is proud to announce that it accomplished cGMP certification for the manufacturing of a first drug-loaded, nanofiber-based pharmaceutical product: the Rivelin® patch, on behalf of one of its clients, Dermtreat ApS.
The Rivelin® patch is a breakthrough therapy for the treatment of mucosal diseases. Manufactured at Bioinicia’s industrial-scale nanofiber production facilities, the Rivelin® patch is a novel, multi-component electrospun product designed for the unidirectional delivery of a pharmaceutical drug to a mucosal surface. As a pharmaceutical product, the manufacturing must be audited and approved by the regulatory authorities to document the required meeting of GMP standards – with the purpose of safeguarding the health of patients.
This GMP approval has been awarded by the Spanish authorities – following shortly after the ISO 9001:2015 and ISO 13985:2016 certification of the manufacturing plant.
Bioinicia is an engineering company dedicated to the development and manufacture of nano- and microstructured materials by electro-hydro dynamic processes (i.e. electrospinning and electrospraying) for its clients, and to providing premium quality equipment for laboratory- to industrial-scale processing.
This latest accomplishment demonstrates Bioinicia’s dedication to providing the highest level of manufacturing service for its clients. Using its expertise in the electrospinning process from laboratory research to industrial manufacture, as well as in the areas of biocompatible materials, encapsulation and drug release, Bioinicia can assist its clients in developing novel pharmaceutical products from concept to market.
Electrospun fibers are an ideal candidate for drug-delivery platforms. Their controllable fiber diameter, in the sub-micrometer range, results in an extremely large active-surface area and highly efficient drug release. Bioactive compounds are dissolved in the fiber matrix, effectively forming a uniform solid molecular solution that ensures high bioavailability even for poorly water-soluble substances. The wide range of materials that can be processed, including food and pharmaceutical grade biopolymers, synthetic polymers and inorganic materials, allows for a variety of drug release profiles, which can be tailored to a specific application. Bioinicia’s electrospinning technology is a room-temperature process which also allows for the processing of thermally sensitive bioactive compounds without the risk of degradation.
“We are proud to be the world’s first GMP approved facility using electrospinning technology for the manufacturing of pharmaceutical products”, says Jose Manuel Valle, CEO of Bioinicia S.L. “We are very excited by the close cooperation with Dermtreat and the many possibilities with the Rivelin® patch, and are looking forward to developing the manufacturing processes for other applications of this strong drug delivery platform”.
“We have been very impressed with the speed and dedication, with which Bioinicia has established an industrial scale, GMP approved manufacturing facility for our Rivelin® patch”, says Jens Hansen, co-founder and CEO of Dermtreat ApS. “Bioinicia will now commence the production of the Rivelin® patch for our clinical Phase 2b study planned to launch in 2Q 2018”.
Bioinicia S.L. is a privately held materials science and engineering company dedicated to the development, industrial scale-up and manufacturing of nano- and microstructured materials by electro-hydro dynamic processes (i.e. electrospinning and electrospraying) for their clients, and providing premium quality equipment for laboratory to industrial-scale processing.
Bioinicia acts as a partner for product development, electrospinning-electrospraying technology and industrial manufacturing.
For additional information, please visit www.bioinicia.com.
Dermtreat ApS is a Danish-based, private, biopharmaceutical company focused on innovative approaches to the treatment of mucosal diseases. Dermtreat’s lead product candidate is using its novel Rivelin® patch for the treatment of Oral Lichen Planus, a chronic condition that affect 1-2% of the population. The Rivelin® patch incorporates clobetasol propionate to treat OLP and is planned to commence a clinical Phase 2b study in April 2018.
Shareholders include Sofinova Ventures, Lundbeckfonden Emerge, Novo Seeds and Welfare Tech Invest.
For additional information, please visit www.rivelin.eu.