As part of the regulatory and commercialisation programme for ArTiMist™, Eastland Medical Systems (EMS) has identified a contract manufacturing organisation (CMO) that it believes will be a strong partner for EMS as it takes the project to commercialisation.
Eastland has signed a contract manufacturing agreement with Therapex, a division of E-Z-EM Canada, which is part of the BRACCO Group. Therapex is a contract manufacturing organisation that was founded in 1968 in Montreal, Canada. It specialises in the development and manufacturing of non-sterile semi-solids and liquids such as ArTiMist.
Therapex is acknowledged by the American FDA, Canadian HPFBI and the European EMEA regulatory agencies and has an outstanding quality and regulatory compliance history.
Therapex will manufacture the registration and validation batches and will be EMS’s primary contract manufacturer of ArTiMist. The agreement is a fee for service agreement and is not a manufacturing licence or a joint venture agreement.
Eastland’s CEO, Stephen Carter, met with the senior management of Therapex in early February and inspected the manufacturing site. Mr Carter believes that Therapex will provide a great service to Eastland and is looking forward to the commencement of the technical transfer and manufacturing of the first commercial scale batches of ArTiMist. The signing of this agreement is a significant step forward for the project and puts it another step closer to completion.