NEWARK, Del., Oct. 22, 2019 /PRNewswire/ -- W. L. Gore & Associates, Inc. ("Gore"), a global materials science company has collaborated with SCHOTT, a pharma packaging specialist to develop a tested and validated option for packaging and delivery of silicone-sensitive biologics. Gore plans to showcase the GORE ImproJect Plunger and SCHOTT will present the syriQ BioPure® silicone-free pre-fillable syringe at the 2019 PDA's Universe of Pre-Filled Syringe and Injection Device meeting in Gothenburg, Sweden on October 22. Gore will be in Booth G5/G10 at the event and SCHOTT will be in Booth F59/F60, to be held at the Swedish Exhibition & Congress Centre.
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 compliance.
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 Dr. Christiane Gumera, Product Specialist, Gore PharmBIO Products.
"Quite often, pharmaceutical manufacturers opt to use vials instead of glass pre-filled syringes to avoid potential drug interaction with silicone," says Nicolas Eon, Global Product Manager at SCHOTT. "With syriQ BioPure® silicone-free pre-fillable syringes and GORE ImproJect Plungers, certain complex, sensitive biologics may now be manufactured and stored in PFS – a packaging class that offers a great way to save time for both patients and clinicians and reduce healthcare costs."
With the commercialization of a silicone-free pre-filled syringe (plunger and barrel), Gore initiated a study to better understand its performance with autoinjectors. Gore will present a poster summarizing the study's findings at the PDA conference on October 22. The poster "Novel Test Method to Assess Consistency of Autoinjection" focuses on the challenges of testing injection time without a physical autoinjector, and describes a robust and rapid method to understand device performance.
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. GORE ImproJect Plunger, like all products in the Gore PharmBIO Products' portfolio, are 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. Gore.com/pharmbio
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world's highest peaks to the inner workings of the human body. With more than 10,500 Associates and a strong, team-oriented culture, Gore generates annual revenues of $3.7 billion. 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.
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