Aesica and EmulTech develop sterile Emulsion Technology for Micro Encapsulation (ET4ME)
CMO’s Nottingham site first to use EmulTech’s ET4ME technology for GMP production of pharmaceuticals
Aesica, the global contract manufacturing organisation (CMO), and EmulTech, jointly announce the commercial development of ET4ME - an innovative emulsion technology for product formulation.
ET4ME, a micro-encapsulation technology developed by the EmulTech group (a spin out of Eindhoven University of Technology), utilises an elegant 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 upon scale up. By utilising a closed system, sterile formulations can be achieved, coupled with resistance to oxidative degradation
The product is already being actively used by an Aesica client to help develop a new dosage form in an acid resistant non-sterile suspension. However, the partners envisage huge growth in the use of this technology for sterile products following an externally validated process simulation trial (PST).
Over three years in development, and thanks to the creation of an aseptic protocol by Aesica, the technology has applications in the formulation of injectables - in particular depot injections for sustained release, due to the uniform droplet size, loading and morphology. Formulations have demonstrated improved aqueous stability that will enable our customers to revisit previously abandoned products such as injectables, poor solubility compounds and new formulations of existing products.
Ian Lafferty, site director at Aesica formulation development, commented: 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 their GMP approved facilities in Nottingham. This coupled with their 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. Thanks to Aesica the process has been PST validated for steriles and there is a clear emerging demand to develop formulations using this approach.”