Overview

Eliminate silicone in both barrel and plunger to protect sensitive biologics in glass pre-filled syringes (PFS)

Today’s complex biologics, such as monoclonal antibodies and conjugate vaccines, can be vulnerable to silicone-induced protein aggregation and particle formation. In addition, over time, silicone migration can impact consistency of delivery, as it may change break loose and glide force (BLGF) and injection time. As a result, many biopharmaceutical manufacturers are actively seeking ways to address these silicone-related issues.

Now, GORE™ ImproJect™ Plungers Offer A New Solution
Silicone-free plunger with PTFE-based fluoropolymer barrer, non-siliconized glass syringe barrel

For the first time, GORE™ ImproJect™ Plungers enable manufacturers to completely eliminate silicone from both plunger and barrel in their PFS.

New GORE™ ImproJect™ Plungers for pre-filled syringes protect complex and sensitive biologics from silicone-induced protein aggregation and particulation. They do so by completely eliminating the need for silicone in both the plunger and the glass barrel.

  • The plungers are silicone-free: Silicone is not a raw material and is not used in the manufacture of the plungers.
  • The plungers, designed for use in bare-glass (non-siliconized) barrels, provide excellent container closure integrity (CCI) and maintain consistent injection performance over time.

Exceptionally Low Particles

GORE™ ImproJect™ Plungers effectively protect many of the more complex biologics that are silicone-sensitive. Testing demonstrates that GORE™ ImproJect™ Plungers provide:

  • Orders of magnitude reduction in sub-visible particles, compared to siliconized syringes.
  • Excellent biocompatibility: 21 CFR Part 4 and ISO 10993-1.
  • No significant extractable compounds, due to our plunger’s proprietary PTFE-based fluoropolymer barrier.

Functional Performance

ImproJect Syringe Plungers

The only plunger that enables low particulates and consistent delivery over time in bare glass (non-siliconized) barrels.

Due to its proprietary plunger design and fluoropolymer barrier, the GORE™ ImproJect ™ Plunger ensures:

  • Excellent CCI, to protect against drug loss, leakage and microbial ingress.
  • Consistent delivery including auto-injector applications – even after accelerated aging conditions.
  • No significant extractable compounds.

 

 

A New Option for Drug Delivery

GORE™ ImproJect™ Plungers provide the only option for a silicone-free PFS (plunger with glass barrel), which protects sensitive biologics from potential interactions with silicone. To explore this new option in drug delivery, connect with your local Gore representative, or contact us.

Compliance & Quality

GORE™ ImproJect™ Plungers are manufactured in accordance with appropriate material and regulatory requirements, including USP <381>, EP 3.2.9 ad JP7.03, and in adherence to relevant Good Manufacturing Processes (cGMP) as defined in the Gore PharmBIO quality system, which is certified to ISO 13485, and ISO 15378.

To read our most current compliance statements, please contact us.

Product Information

For additional product information, please review our Data Sheet. To request a technical consultation, product samples, or a Validation Guide, please contact us.

Resources

Recent News

Press Release

Gore PharmBIO Introduces 116mL and 232mL Protein Capture Devices with Protein A to Increase Productivity and Throughput for Antibody Purification

Posted April 5, 2022

W.L. Gore & Associates, Inc. continues to build on its growing portfolio of protein capture devices with the introduction of its new 116mL and 232mL GORE® Protein Capture Devices with Protein A. The offerings strengthen Gore’s chromatography device portfolio and follow the commercial availability of its 58mL Protein Capture Device in Q4 of 2021.

Event

Visit GORE at World ADC Europe 2022

March 29, 2022 - April 1, 2022

Visit GORE in-person or virtually at this year’s World ADC Europe. Gore is participating as an exhibition partner to showcase expertise in providing leading pharmaceutical companies with an innovative, Protein A membrane chromatography device to improve productivity in affinity purification of monoclonal antibodies. Discuss how a membrane column could be the missing single use purification link.

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Visit GORE at Bioprocessing Summit Europe

March 22, 2022 - March 24, 2022

Visit GORE at Bioprocessing Summit Europe 2022 March 22, 2022 - March 24, 2022 Barcelona, Spain

Press Release

ViaCyte and Gore Enter Clinical Phase Agreement Based on Novel Membrane Technology for PEC-Encap Product Candidate

Posted August 5, 2020

Clinical evaluation of PEC-Encap has resumed using sentinels created with the novel membrane; preclinical and initial clinical data suggest the novel membrane can mitigate the foreign body host response.

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