Breakthrough technologies for Glass prefillable syringe for injectable Biopharmaceuticals

摘要

Chronic diseases management lead to very specific and challenging set of requirements for the prefillable syringe (PFS) used. Glass PFS based solutions still remains the gold standard that offers a large range of options for injectable biopharmaceuticals.?A complete overhaul and redesign of the Glass PFS manufacturing process, through a quality by design approach and the introduction of innovative and best in class technologies (have increased significantly the syringe performances until the level required to meet the best in class product specifications with BD NeopakTM?BD Neopak XsiTM coating, as an inert & immobilized cross-linked silicone for an optimized interfacial contact with biologics, has been developed to maximize the compatibility of the container with the drug product and increase the performance of BD NeopakTM by eliminating the contribution of the container to the Subvisible particles.?BD Neopak DuraShieldTM, results from a specific treatment in a molten bath of neat potassium nitrate (KNO3 molten salt), that enables ions exchange at an atomic level putting the glass under compression. Such treatment increases significantly the BD NeopakTM breakage resistance and durability (that presents already high level of performance for these criteria) opening the way to overcoming none controlled challenging situations, but at a much higher acquisition cost.