Aesica and EmulTech claim a new sterile formulation technology could help drugmakers resurrect abandoned projects and extend the lifespan of marketed medicines.
The technology in question – ET4ME – is a micro-encapsulation system used to improve API (active pharmaceutical ingredient) bioavailability that was developed by scientists at University of Eindhoven spin out company, Emultech.
Aesica’s role in the project has been the development of sterile manufacturing protocols that mean ET4ME can be used to create injectable formulations of poorly soluble APIs, which the CMO (contract manufacturing organisation) believes has advantages over other coating techs.
“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.”
Development of ET4ME for manufacturing processes is being conducted at Aesica’s facility in Nottingham, UK according to site director Ian Lafferty, who said the firm had focused on making it usable for a wider range of formulations.
“We first came across the technology at a conference a few years ago and realised that if we could develop an aseptic process…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.”
The unique selling point of the EmulTech system is precision according to Aesica spokeswoman Georgina Linscott who told in-pharmatechnologist.com that: “Microparticle size is controlled by the mechanics of the system of manufacture. The mechanics are not variable and are selected before the equipment is built.”
This eliminates batch-to-batch variation Linscott explained adding that despite this precision the cost of setting up the system is comparable with other encapsulation technologies.
The collaboration – terms of which were not provided – is one of a number Aesica has formed with a partner with links to academia.
Last year at CPhI in Madrid, Spain Aesica marketing director Alan Raymond told us that partnering with academic allowed the firm to add cutting edge technologies to its manufacturing offering citing the firm’s collaboration with a team from the University of Bradford as an example.
More recently the CMO partnered with researchers at the Universities of Durham and Leeds on a project focused on using innovative manufacturing technologies to improve the efficiency of its facility in Cramlington.