NewswireToday - /newswire/ -
Mainz, Rhineland-Palatinate, Germany, 2019/11/05 - International technology group SCHOTT has collaborated with W.L. Gore & Associates, a global material science company, to offer a tested and validated option for the packaging and delivery of complex biologic drugs - GORE.com / SCHOTT.com.
Silicone has long been a necessary substance for pre-fillable syringes to help reduce the injection force needed to administer drugs, making the treatment more comfortable for the patient. Yet, silicone may interact with and harm the drug. Pharmaceutical packaging specialist SCHOTT has collaborated with W.L. Gore & Associates (gore.com) to pare GORE ImproJect Plungers with syriQ BioPure® silicone-free1 syringes. Together, we present the first pre-fillable glass syringe (PFS) system that completely eliminates the need for silicone or similar substances. SCHOTT and GORE will highlight this collaboration at CPhl Worldwide in Frankfurt, Nov. 5-7.
The collaboration helps meet the needs of the growing market for biologics that are ultra-sensitive to silicone, which applies to an estimated 10 to 15 percent of the global biologics pipeline.
“Biologics stored in pre-fillable glass syringes can come into contact with up to seven components that have the potential to leach and interact,” said Dr. Nicolas Eon, Senior Global Product Manager at SCHOTT. “This product allows a new class of drugs to be manufactured and stored in pre-fillable syringes a packaging class that offers a great way to save time for clinicians, reduce healthcare costs and improve patient safety.”
syriQ BioPure® silicone-free1 syringes use no silicone inside the syringe barrel. To maintain a consistent gliding force and injection duration over the shelf life of the product on one side, and provide a robust container closure integrity on the other side, great emphasis was given to an accurate geometry. The new syringes are made of FIOLAX® CHR® glass tubing that is 100 percent inspected with the help of a big data process named perfeXion®, ensuring tight dimensions and a high cosmetic quality of each barrel. In addition, syriQ BioPure® silicone-free1 also features ultra-low tungsten residuals as well as low cannula adhesive residuals to lower the extractible profile and reduce risk of container/drug interactions.
The barrels will now be offered with GORE ImproJect silicone-free2 plungers the industry’s leading silicone-free plunger to further eliminate the risk of container interaction with sensitive biologics. GORE ImproJect Plungers eliminate the need for silicone as a lubricant in pre-filled syringes. Designed for use in bare-glass (non-siliconized) barrels, these plungers can help to protect complex or sensitive biologics from silicone-induced aggregation and particulation while maintaining consistent injection performance over time.
“Pharmaceutical manufacturers seeking to avoid silicone induced aggregation and sub-visible particles have had to choose vials even when they wanted to offer other delivery options,” said Christiane Gumera, Product Specialist at GORE. “With this collaboration, we’re reducing or eliminating time spent on reformulation when transitioning from vials to pre-filled syringes.”
Together, the GORE ImproJect Plunger and syriQ BioPure® silicone-free1, pre-fillable glass syringes provide the only commercial option for a silicone-free, pre-filled syringe system (plunger and barrel) that protects sensitive biologics from potential interactions with silicone.
1. Silicone oil residuals inside the glass barrel below the detection limit
2. Silicone oil is neither a raw material, nor used in the manufacture of the plungers
SCHOTT (schott.com) is a leading international technology group in the areas of specialty glass and glass-ceramics. The company has more than 130 years of outstanding development, materials and technology expertise and offers a broad portfolio of high-quality products and intelligent solutions. SCHOTT is an innovative enabler for many industries, including the home appliance, pharma, electronics, optics, life sciences, automotive and aviation industries. SCHOTT strives to play an important part of everyone’s life and is committed to innovation and sustainable success. With more than 15,500 employees at production sites and sales offices in 34 countries, the group has a global presence. In the 2017/2018 fiscal year, SCHOTT generated sales of around $2.5 billion.