NEWARK, Del. (October 3, 2018) – W. L. Gore & Associates, Inc. (“Gore”), a global materials science company, plans to commercially launch the GORE™ ImproJect™ Plunger for Pre-Filled Syringes at the 2018 PDA’s Universe of Pre-Filled Syringe and Injection Device meeting in Orlando, FL on October 8th. Gore will be in Booth 313 at the event, to be held at the Loews Royal Pacific.
Conventional pre-filled syringe systems use silicone to help provide a seal and to act as a lubricant between the barrel and the plunger. However, there can be problems associated with silicone impacting broader drug stability for some highly complex sensitive biologics. Silicone oil has been shown to cause aggregation and particle formation in therapeutic proteins.1, 2 In addition, silicone migration can impact consistency of delivery as break-loose-glide forces change over time, which may impact injection performance and affect patient comfort.
By eliminating the need for silicone from the barrel and the plunger, the GORE ImproJect Plunger may enable today’s more challenging sensitive biologics to be administered in a pre-filled syringe, a practice that may not have been an option with traditional siliconized pre-filled syringe systems.
About Gore PharmBIO products
Our technologies, capabilities, and competencies in fluoropolymer science are focused on satisfying the evolving product, regulatory, and quality needs of pharmaceutical and bioprocessing customers, and medical device manufacturers. The GORE ImproJect Plunger, like all products in the Gore PharmBIO Products’ portfolio, is manufactured in a manner that adheres to relevant current Good Manufacturing Practices (cGMP) as defined in the stringent Gore PharmBIO Products’ quality system which is certified to ISO 13485 and ISO 15378.
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Founded in 1958, Gore has built a reputation for solving complex technical challenges in the most demanding environments — from revolutionizing the outerwear industry with GORE-TEX® fabric to creating medical devices that improve and save lives to enabling new levels of performance in the aerospace, pharmaceutical and mobile electronics markets, among other industries. The company is also known for its strong, team-oriented culture and global recognition from the Great Place to Work® Institute. Headquartered in Newark, Del., Gore employs 9,500 Associates and generates annual revenues of $3.5 billion. www.gore.com
1 Basu P, Blake-Haskins AW, O’Berry KB, Randolph TW, Carpenter JF. Albinter-feron a2b adsorption to silicone oil-water interfaces: effects on protein conformation, aggregation, and subvisible particle formation. J Pharm Sci. 2014;103(2):427-436.
2 Gerhardt A, Bonam K, Bee JS, Carpenter JF, Randolph TW. Ionic strength affects tertiary structure and aggregation propensity of a monoclonal antibody adsorbed to silicone oil-water interfaces. J Pharm Sci. 2013;102(2):429-440.