CMO’s Nottingham site first to use ET4ME technology for GMP production of pharmaceuticals
Aesica, a UK-headquartered contract manufacturing organisation (CMO), is to develop EmulTech’s ET4ME emulsion technology for product formulation.
ET4ME, a micro-encapsulation technology developed by the EmulTech group (a spin out of Eindhoven University of Technology in The Netherlands), uses a micro fluidic process to create a measurable micro particulate suspension where particle size is uniform and reproducible. The technology can be used for a multitude of APIs from small molecules to complex biomolecules, with high levels of batch consistency and reproducibility on scale up. By using a closed system, sterile formulations can be achieved, coupled with resistance to oxidative degradation.
One of Aesica’s clients is already using the product to help develop a new dosage form in an acid resistant, non-sterile suspension. The partners envisage growth in this technology for sterile products following an externally validated process simulation trial (PST).
Already, we have started working with several clients to commercialise this technology
More than three years in development, and thanks to the creation of an aseptic protocol by Aesica, the technology has applications in the formulation of injectables, particularly depot injections for sustained release, because of the uniform droplet size, loading and morphology.
Aesica says formulations have demonstrated improved aqueous stability that will enable customers to revisit previously abandoned products.
Ian Lafferty, site director at Aesica formulation development, said: ‘We first came across the technology at a conference a few years ago and realised that if we could develop an aseptic process – it’s a tremendous credit to our development team that we could achieve this – it would provide an elegant solution to many compounds. Already, we have started working with several clients to commercialise this technology and there is a tremendous growth opportunity for sterile products and injectables.’
Fränk de Jong, CEO at EmulTech, added: ‘We knew we had a very innovative proprietary technology and by working with Aesica we now have access to the company’s GMP approved facilities in Nottingham. This coupled with Aesica’s ability to develop an aseptic process for the technology has enabled us to offer a commercialised solution that has the potential to develop formulations that would previously have been unachievable.’