Record #233503 - GSI Repository

miPLUNGER

Novel premium pre-filled syringe plunger made by micro- /injection moulding for innovative drug delivery systems and auto injectors

Coordinator	MDX DEVICES GMBH
Grant period	2019-08-01 - 2020-01-31
Funding body	European Union
Call number	H2020-SMEInst-2018-2020-1
Grant number	874801
Identifier	G:(EU-Grant)874801

Note: The global pre-filled syringes (PFS) market has currently a volume of more than 4 billion USD and is growing with a CAGR of 10% due to the increase of chronic diseases, growing demand of biologics and biosimilars and a high penetration rate of autoinjection devices. The segment of autoinjectors grows even faster with a CAGR of 24%. But there are challenges, that cannot be fully solved by the current generation of rubber syringe plungers. Biologics are very sensitive to any leachables, that can be extracted from the syringe components. Self-injection devices need an excellent gliding behaviour of the plunger to minimise patients pain-experience during the injection. The innovative miPLUNGER can solve these challenges by introducing a cost-efficient two component TPE/PFA plunger element, that is manufactured in a reliable two-step micro injection moulding process. The new material is inherently free of any harmful leachables and provides excellent gliding behaviour. The process allows a cost-efficient sterile production under cleanroom conditions in just two process steps and a high flexibility in the plunger design. MDX’ customers are the PFS manufacturers, the primary users of miPLUNGER will be producers of sensitive high-value drugs and those of advanced self-injection devices. MDX will cooperate with them early in their drug and device development to create a growing market for miPLUNGER. By making and selling its new plungers to the PFS producers, MDX anticipates a turnover of 9.6 million €, and an total staff headcount of 28 employees in 2024. In the feasibility study, a detailed analysis of the best-fitting market segments will be conducted, including the cooperation with pilot customers for the validation of the business idea, as well as the elaboration of a thorough business plan for commercialisation. The results of the feasibility study will be integrated into the subsequent SME Phase 2 project to facilitate the commercial launch of miPLUNGER.

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Record created 2020-09-04, last modified 2023-02-08

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