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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - LUBRIGONE (The first lubrication- and coating-free stoppers for Prefillable Syringes)

Teaser

Summary

Stoppers in prefilled syringes (PFS) today are made of butyl rubber. This material contains leachable substances that must be coated to avoid harming the drugs and ultimately the patient. Silicone oil must be used to lubricate stoppers to ensure the injection system functionality, but it may cause the formation of protein aggregates in biopharmaceutical drugs, reducing its efficacy and potentially causing immunogenic response in patients. LUBRIGONE3 is a silicone oil free and coating free PFS stopper made of a chemically inert Thermoplastic Elastomer (TPE) with a unique profile design allowing it to function without lubrication means. Since our TPE does not release particles nor interacts with the drugs, LUBRIGONE3 eliminates the risk of potential harmful reactions in patients. So far, we have reached TRL6 and we aim to validate our manufacturing process to comply with the cleanliness requirements of pharmaceutical companies and produce under these conditions the samples that will be tested in large-scale.

Work performed

On the technical side, we analysed the customer predilection to define the design of the preferred stopper and prepared the manufacturing of the hard moulds that will be validated to produce samples in large scale in 3 different sizes. We also outlined our technical execution plan and performed a technical and commercial risks assessment. To ensure business success, we updated our commercialisation plan through a deep market analysis, explored distribution opportunities and prepared a strong marketing strategy. We also confirmed our FTO and established our IPR strategy. Regarding financials, we assessed the cost-benefit of scaling up stopper production, proved the economic viability of the project through the sales projections for 5 years after entering the market and estimated the investment that would be needed for its execution.

Final results

LUBRIGONE3 is the only silicone-oil and coating free stopper compatible with PFS in glass or COC/COP. It is 100% safe, allowing injectables to be stored for long periods without contamination nor health risks. Its moulding process requires max. 3 production steps vs. â‰¥7 for butyl rubber stoppers, which reduces time production from 8-10 min. and down to ~15 sec. per unit and significantly minimizes material and energy consumption. Besides, our solution aids to remedy drugs waste by reducing overfilling (from 10-25% on vials to less than 2% in a PFS), allowing pharmaceutical companies to save more than 20% of drugs.