Project: Development of a pharmaceutical printing system supporting personalized therapy in oncology and in the paediatric population.

>>>>> BACKGROUND OF THE PROJECT <<<<<_x000D__x000D_Personalized medicine has now become a clear and actual medical need. The goal is to provide physicians the flexibility to tailor the administration dose or profile exactly to the needs of the specific patient or patient population. As of today, no technical solution for manufacturing individualized pharmaceutical dosage forms with tailored amounts of drug substances in an automated, verifiable, robust and safe manner is available. The project consortium proposes to develop a practical approach for personalized medicine providing an “advanced galenic” solution: pharmaceutical dosage forms directly manufactured at the hospital pharmacy based on the prescription for the specific patient or patient population. _x000D__x000D__x000D_>>>>> GOAL OF THE PROJECT <<<<<_x000D__x000D_The goal is to develop the first commercial drug substance printing system for personalized medicine applications. This system will provide the following possibilities:_x000D__x000D_* Drug substances can be printed on demand, based on the requirements of a specific patient, with unprecedented precision_x000D__x000D_* Multiple drug substances can be printed onto a single dosage form (e.g., personalization of fixed-dose combinations)_x000D__x000D_* Drug substances can be separated and drug release can be modified by applying different coating materials or by adjusting the thickness of the printed coating layer_x000D__x000D_* Printed dosage forms can be administered perorally (either directly or after inserting the material into a gelatine capsule). Printed oral thin films are for buccal delivery_x000D__x000D_* The system will have a built-in chemical imaging system to assess identity, quantity and distribution of the printed drug substance(s)_x000D__x000D_* The system will provide a user-friendly and flexible platform designed for daily use in a hospital’s pharmacy_x000D__x000D__x000D_>>>>> ADDED VALUE <<<<<_x000D__x000D_> For the patient <_x000D_Drastically increased patient compliance due to:_x000D_* prompt adjustment of the dose based on clinical outcome or medical need, directly done at the hospital where the patient is treated_x000D_* the risk of under- or over-dosing is dramatically reduced_x000D_* tailored fixed-dose combinations possible_x000D_* possibility to combine different release profiles or dose regiments based on the requirements of a specific patient or a target patient population_x000D__x000D_> For the Healthcare provider <_x000D_* The dosage is not fixed upfront anymore (e.g. manufacturing and packaging of pre-defined strengths) but directly defined by the physician_x000D_* A direct feedback loop between prescription, dosage form manufacturing and therapeutical effect can be established resulting in an effective and active system of dose adjustment lead by the physician_x000D__x000D_> For the pharmaceutical industry <_x000D_* Possibility of dosing even highly potent drug substances with unprecedented precision and a high level of safety for operators_x000D_* Simplification of regulatory compliance and lower risk of out of specification products due to real time release testing_x000D_* A new business model for new and established drug substances is provided, also offering the possibility of renewing patent protection with printable liquid formulations_x000D__x000D__x000D_>>>>> MARKET POTENTIAL <<<<<_x000D__x000D_Personalized medicine often requires a level of information regarding a patient that is not yet available. In the future, a patient's proteomic, genetic and metabolic profile will be investigated in order to tailor a therapy to his/her specific needs. Thus, methods and tools supporting personalized medicine have great potential. _x000D_This project aims not only at future applications, but at the existing market for personalised medicine. Based on discussions with physicians, the project’s consortium targeted two medicinal fields of applications: supportive therapy in oncology and the paediatric population, both of which urgently require innovative technological solutions._x000D_The market potential of the personalised pharmaceutical drug substance printing system is estimated to be in the order of 400+ units in Austria and Germany and 2000+ in the European Union for target applications in oncology and in the paediatric population. After a successful initial market introduction in these two fields of application, the technology may be transferred to other applications and its significant market potential may be developed further._x000D__x000D__x000D_>>>>> PROJECT’S CONSORTIUM <<<<<_x000D__x000D_The project will be coordinated by Scienion AG, an R&D performing SME specializing in ultra-low volume liquid handling and microarray technologies. The project’s participants are Research Center Pharmaceutical Engineering GmbH (RCPE), an interdisciplinary research institute for pharmaceutical process and product development, and EVK GmbH, an R&D performing SME specializing in chemical and color imaging systems. The project’s consortium will include the medical advisors Prof. Hellmut Samonigg (Director of Division of Oncology, Medical University of Graz,) and Prof. Berndt Urlesberger, (1st subst. Director of the Division of Neonatology, Medical University of Graz)._x000D_

Acronym MediPrint (Reference Number: 7761)
Duration 01/04/2013 - 31/12/2015
Project Topic Development of an innovative pharmaceutical printing system for personalized therapy based on a printing process of drug substances and functional components at hospital pharmacies in the exact amount and combination prescribed to a specific patient or a target patient population.
Network Eurostars
Call Eurostars Cut-Off 9

Project partner

Number Name Role Country
3 Scienion AG Coordinator Germany
3 EVK DI Kerschhaggl GmbH Partner Austria
3 Research Center Pharmaceutical Engineering GmbH Partner Austria