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

Periodic Reporting for period 1 - miPLUNGER (Novel premium pre-filled syringe plunger made by micro- /injection moulding for innovative drug delivery systems and auto injectors)

Reporting period: 2019-08-01 to 2020-01-31

With the growing number of people affected by civilisation diseases like diabetes, cancer, or arthritis the safe self-medication of patients is more and more in the focus of attention, especially in times of shortage of skilled professionals. Therefore, systems for the error-free and safe application of medications such as pre-filled syringes, autoinjectors or infusion pumps are gaining importance. For a smooth and painless injection of medicament with these devices, the gliding behaviour is crucial. In this context the rubber plunger is the key element. But there are challenges, that cannot be fully solved by the current generation of rubber plungers. Biologics are very sensitive to any leachables that can be extracted from the syringe components.
MDX Devices has developed an innovative plunger that can solve the challenges by introducing a cost-efficient two component plunger element, which is manufactured in a reliable two-step micro injection moulding process. The new plunger is inherently free of any harmful leachables and provides excellent gliding behaviour. The process allows a very cost-efficient fully sterile production under cleanroom conditions with just two process steps, a high flexibility in the plunger design and has the potential to add further process steps in the future, e.g. for an integrated plunger-rod element.
In the feasibility study, the economic and technical validation of the plunger prototypes and of the planned business should be performed, verifying the best-suited applications and key markets for the initial market introduction of this very innovative plunger. By bringing our innovation successfully into the market we enable our customers to provide patients with medication solutions which ensure optimal efficacy of the active agents and a minimal pain experience during injection.
During the phase 1-project technological applications for the new plunger have been identified, evaluated and prioritised. The market has been assessed according to the different types of devices where the new plunger can be applied and according to the relevance of different fields of applications (diseases/ active ingredients), and attractive market segments could be identified. Further, the competitive landscape was analysed. For the most attractive market segment appropriate commercialisation strategies were created. Finally, a business plan was elaborated to assess the profitability of the business innovation.
The innovative miPLUNGER is a cost-efficient two component plunger element, which 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. Due to its excellent chemical stability it is universally applicable to a wide range of different drugs.With these properties it addresses decisive shortcomings of current state of the art solutions.
The unique manufacturing process allows a very cost-efficient fully sterile production under cleanroom conditions with just two process steps, a high flexibility in the plunger design and has the potential to add further process steps in the future, e.g. for an integrated plunger-rod element. European health systems are facing big challenges due to aging populations, a rise in chronic diseases and current constraints on public finances. A rising share of user-friendly devices, that enable a safe self-administration of parental drugs, especially for chronical patients, can ease some of this financial pressure. Our innovation supports this development and improves the patient’s comfort by providing injection solutions which ensure optimal efficacy of the active agents and a minimal pain experience during injection.
Syringe with rod and new plunger prototype