contractpharmaMarch 28, 2019
Tag: STABILITY , GORE , Pre-Filled
W.L. Gore & Associates, Inc. has launched the GORE ImproJect Plunger for Pre-Filled Syringes, a solution for silicone-sensitive biologics.
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, silicone can impact drug stability for some highly complex and sensitive biologics. Silicone oil has been shown to cause aggregation and particle formation in therapeutic proteins, and silicone migration can impact injection performance. Also, 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 can enable 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."
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