W. L. Gore & Associates, Inc., a global materials science company, recently announced the commercial launch of the 0.5 mL silicone-free GORE IMPROJECT Syringe Plunger within its PharmBIO business. The new offering is specially designed for prefilled syringes used in various applications, including ophthalmic intravitreal injections, and complements the GORE IMPROJECT 1 mLL plunger which Gore launched in mid-2018.
Conventional pre-filled syringe systems use silicone to provide a seal and act as a lubricant between the barrel and the plunger. However, peer reviewed literature highlights various problems with silicone including elevated subvisible particulate levels, silicone accumulation in the eye resulting in floaters, silicone-induced protein aggregation resulting in immunological responses, and ocular inflammation and increased intraocular pressure (IOP). In addition, silicone-containing syringes have been associated with particle count increases and fatty acid creation over time.
The new plunger enabled syringe systems to achieve particulate levels below the limits of the USP<789> subvisible particle standard in testing performed. The plunger is capable of being terminally sterilized and has been shown to provide suitable break loose and glide force (BL/GF) and CCI performance when used in combination with appropriate syringe components and commercial fill and finish processes.
To develop this new product Gore worked closely not only with pharma companies, but also CMOs, terminal sterilization companies, machine companies that design equipment for fill operations, and leading syringe barrel suppliers to bring forth the 0.5 mL silicone-free GORE IMPROJECT Plunger for pre-filled syringes.
The GORE IMPROJECT Plunger may enable today’s more challenging ophthalmic injections without the need to introduce silicone oil, cross-linked silicone or resin enhanced silicone. With increasing needs for precise, low-volume injections in ophthalmology, gene therapy, and pediatric care, Gore’s 0.5 mL prefilled syringe plunger offers a new alternative. Designed for silicone sensitive applications, this innovation underscores Gore’s commitment to enhancing patient outcomes and to driving growth in the evolving injectable therapeutics market.
