Rigorously compliant to meet the changing needs of our global customers, Gore’s solutions for pharmaceutical and biopharmaceutical manufacturers include a suite of efficient, technology-driven products for single- and multi-use applications.
In the pharmaceutical industry, manufacturers must ensure the purity of their materials and the efficiency of their processes. Starting with the introduction of the GORE® LYOGUARD® Freeze-Drying Tray, a single-use bulk lyophilization container, Gore has developed many single- and multi-use products and process components for transferring, storing, filtering and drug processing.
We collaborate with manufacturers to design the solutions that fit their requirements for purity and help maximize process effectiveness. As with many Gore products, our life sciences solutions can provide high value by:
What differentiates Gore’s life sciences solutions is our deep understanding of fluoropolymers, particularly polytetrafluoroethylene (PTFE) and its expanded form. By utilizing our materials expertise we can design products with properties like low extractables and resistance to chemicals and extreme temperatures – for solutions that perform efficiently and more reliably than alternatives.
Silicone-free GORE ImproJect Plungers minimize the risk of silicone-induced interaction
The GORE® IMPROJECT® Plunger is designed to protect complex, silicone-sensitive biologics in pre-filled syringes. Our proven approach to eliminate silicone in glass pre-filled syringes enables low particulates—eliminating the risk of silicone particles and silicone-induced aggregation—while maintaining consistent delivery and consistent injection time with aging. Silicone oil is neither a raw material, nor used in the manufacture of the GORE IMPROJECT Plunger. Additionally, the plungers are designed to work with bare glass (non-siliconized) barrels and testing demonstrates no significant extractable compounds, due to our plunger’s proprietary PTFE-based fluoropolymer barrier.
The GORE® Protein Capture Device for affinity chromatography uses the unique properties of a proprietary ePTFE composite combined with Protein A to fundamentally improve the purification process. Designed for drug discovery and screening, and process development applications, it provides significant capacity and speed improvements in the purification of monoclonal antibodies.
GORE® STA-PURE® Pump Tubing enables reliable peristaltic pump operation in challenging pharmaceutical and biopharmaceutical processing applications. As biopharmaceutical manufacturing changes to accommodate continuous processing, enabling technologies like peristaltic pump tubing must also adapt. Conventional pump tubing will be challenged to achieve desired performance goals such as long runs, elevated pressures, and rigorous CIP/SIP cleaning. GORE STA-PURE Pump Tubing, Series PCS, has been shown to perform in these demanding conditions.
The GORE® STA-PURE Flexible Freeze Container helps minimize the risk of losing valuable bulk drug substances during cold chain handling. Unlike other disposable storage containers which may become brittle after freezing down to -86°C, the single-use GORE STA-PURE Flexible Freeze Container uses a unique combination of PTFE composite film with low extractables and an innovative bag design to remain robust and resist breaks, cracks or leaks.
All Gore products for life sciences are manufactured specifically for use in medical device manufacturing or pharmaceutical settings and comply with regulations our customers may require. Depending upon those requirements, you will find products manufactured under Good Manufacturing Practices (GMP), ISO 13485 and ISO 15378 certifications; and/or regulations for food contact.
This evaluation demonstrates a method to extend the lifetime of a GORE Protein Capture Device from 20 to 50 cycles while maintaining capacity as assessed by Dynamic Binding Capacity (DBC) at 10% breakthrough, yield, and purity.
Gore’s rigorously compliant, technology-driven products and process components designed for efficiency, reliability and contamination control.
GORE STA-PURE Pump Tubing Series PCS is a durable, resilient tubing product used in peristaltic pumps and is suitable for pharmaceutical and biopharmaceutical manufacturing. The product delivers consistent flow rate and low incidence of rupture, even at operating pressures up to 100 pounds per square inch gauge (psig), thus enabling the pump to work reliably under challenging conditions.
This document is available upon request.
Recommendations for tray handling during filling, dryer loading/unloading, product sampling and removing or reconstituting dried product.
