W.L. Gore & Associates, Inc. , a global materials science company, plans to attend Pharmapack Europe (www.pharmapackeurope.com) on February 6th and 7th, 2019, to continue their year-long launch of the GORE™ ImproJectTM Plunger for Pre-Filled Syringes.
Commercially launched last year at the 2018 PDA's Universe of Pre-Filled Syringe and Injection Device meeting, this solution for silicone-sensitive biologics has been well-received by the industry. Gore will be in Booth A42 at the Pharmapack event, to be held at the Paris Expo, Porte de Versailles in Paris, France.
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 injection performance. And, the break-loose-glide forces may change over time, affecting injection time and 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.
"Our approach eliminates the need for silicone in both plunger and glass barrel, while ensuring the functionality and performance of pre-filled syringes" said Christiane Gumera, Product Specialist, Gore PharmBIO Products. "Additionally our plunger's
PTFE-based fluoropolymer barrier provides protection from extractable compounds found in butyl rubber."
"We look forward to discussing this technology with our pharmaceutical customers, and our value chain partners at Pharmapack Europe, and continuing the conversation about the potential benefits of the Gore solution for our pharmaceutical and biopharmaceutical customers."
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™ ImproJectTM 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.