Project description
Patients can look forward to safer syringes to help them treat their chronic conditions
Injection moulding is used by the huge global plastics industry to produce a variety of industrial and consumer goods. More recently, the technique that was first patented in 1872 as a machine more like a large syringe is now being used to make pre-filled syringes. While micro-injection moulding has evolved into a field of its own, the current generation of rubber syringe plungers face limitations in terms of leaching and mechanical discomfort of use. miPLUNGER has developed materials and techniques leading to cost-efficient sterile production of a smooth-gliding plunger element free of harmful chemicals that can leach into the stored product. With EU support, the team is conducting the feasibility study needed to get it to market.
Objective
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.
Fields of science
Not validated
Not validated
Keywords
Programme(s)
Funding Scheme
SME-1 - SME instrument phase 1Coordinator
78652 Deisslingen
Germany
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.