Stevanato Group is excited to announce a significant milestone for the Alba EZ-fill® platform. We have now released the first batch of syringes for human use in clinical trials. We have also successfully completed a full validation of the Alba line and commenced qualification of the entire Alba Portfolio.
‘’The Alba Platform is the ideal solution for de-risking the development process, helping to reduce costs and enabling a much faster introduction to the market.’’ says Alessandro Morandotti, Senior Products Platform Leader.
Qualification of New Formats And New Rubber Components
We know that drugs are not all the same, and this is perhaps most relevant in biologics. For this reason, we are progressing with the qualification of more than thirty new formats, which will soon be included within the Alba EZ-fill® portfolio.
To deliver the maximum flexibility for clients and ensure the maximum integrity of the drug, we are also introducing new rubber components with different extractable, leachables, and permeability levels.
“These developments have broadened the potential applications for Alba syringes and positioned it as a truly groundbreaking solution within our industry.” continues Alessandro Morandotti.
Maximizing End-User Safety through an Integrated Safety System
Driven by a desire to increase patient safety and reduce needlestick injuries, Stevanato is studying the implementation of the Integrated Safety System (ISS) on Alba syringes to extend the options of primary packaging for Biological Drug Product.
Using minimal components, this simple design replaces the traditional needle cover on a ready-to-fill glass syringe with a fully comprehensive, integrated safety solution for the end-user. Crucially, there is no change to the primary container and it can be assembled by most processing lines with minimal disruption.
“The ISS bridges the gap when speed-to-market or entry-pricing is critical to the launch path of an injectable drug.” explains Mr. Morandotti, Senior Products Platform Leader.
By giving pharmaceutical companies the ability to market their products immediately, in parallel with or without a full drug delivery device program, Stevanato Group enables the realization of a quicker return on investment for their drug formulations.