Pharmaceutical & Biopharmaceutical
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.
Overview
The breathability of ePTFE gives GORE® LYOGUARD® Freeze-Drying Trays its superior vapour transmission rate.
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 lyophilisation product, 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 maximise process effectiveness. As with many Gore products, our life sciences solutions can provide high value by:
- protecting and containing complex biologics
- supporting speedy processing times
- enabling secure fluid transfer and sampling
- minimising process disruption errors or issues
What differentiates Gore’s life sciences solutions is our deep understanding of fluoropolymers, particularly polytetrafluoroethylene (PTFE) and its expanded form. By utilising our materials expertise we can design products with properties like low extractables, high surface area, and resistance to chemicals and extreme temperatures for solutions that perform efficiently and more reliably than alternatives.
GORE™ Protein Capture Device for small-scale 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 applications, it provides significant capacity and speed improvements in the purification of monoclonal antibodies.
Our newest product, the GORE® STA-PURE™ Flexible Freeze Container, helps minimise the risk of losing valuable bulk drug substances during cold chain handling. Unlike other disposable storage containers that may become brittle after freezing down to -86°C, the new 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.
Good Manufacturing Practices
All Gore products for life sciences are manufactured specifically for use in medical device manufacturing or pharmaceutical∘applications and comply with the regulatory requirements of our customers. Depending on those requirements, you will find products manufactured in a manner that adheres to current Good Manufacturing Practices (cGMP), as defined in the Gore PharmBIO products quality system which is certified to ISO 13485 and ISO 15378.
Single-Use Frozen Storage
In downstream bioprocessing, a common concern is the risk of losing frozen product in single-use containers during handling, transport and storage. Single-use GORE® STA-PURE™ Flexible Freeze Containers offer a new solution for bulk drug substance that protects container integrity with enhanced crack and impact resistance during cold chain handling. This increased durability combined with the low extractables profile of the high-purity fluoropolymer container material gives added peace of mind.
Single-Use Frozen Storage
Chromatography
Traditional protein purification processes may be time consuming and slow down small-scale drug discovery or antibody production operations. The GORE™ Protein Capture Device with Protein A eliminates those constraints. It combines high dynamic binding capacity with short residence times for the possibility of more highly-concentrated elution pools in less time.
Chromatography
Lyophilization
Developed in consultation with the pharmaceutical lyophilization industry, GORE® LYOGUARD® Freeze-Drying Trays provide a cost-effective method of freeze-drying by containing product throughout the lyophilization process.
Lyophilization
Peristaltic Pump Tubing
A failure during processing due to tubing rupture is just not an option. A significant loss of flow can be disruptive — manufacturers need consistent, repeatable and reliable results, every time. That’s why GORE® STA-PURE® Pump Tubing products are engineered to meet varied process challenges: to reliably protect against ruptures even at high pressures… to resist aggressive chemicals… to deliver consistent flow rates in peristaltic pumps for days, weeks, or even months.
Fluid Transfer and Sampling
The secure transfer and containment of liquids is paramount in pharmaceutical and biopharmaceutical processing. Gore offers a family of fluid transfer and sampling products to meet a variety of different pharmaceutical and bioprocess applications.
GORE™ Molded Assemblies are configured to individual customer requirements and may include platinum-cured silicone and thermoplastic elastomer (TPE) tubing, molded connections, unions and manifolds, clamps, and bottle top assemblies.
Patent and License Information
These GORE Molded Assemblies and components may be protected under the following patents:
GORE™ Molded Assemblies are licensed under U.S. Patent Nos: 6,290,625 and 7,093,859.
GORE™ Aseptic Sampling Valves and assemblies, and Crimp and Cut tools, are licensed under one or more of the following: United States Patent No. 7,293,477, United States Patent No. 7,927,316, and United States Patent No. RE41,169.
ReadyMate™ connectors are manufactured and supplied by GE Healthcare under an exclusive license to US patent number 6,679,529 and equivalent patents and applications in other countries owned by Johnson and Boley Holdings. ReadyMate is trademark of GE Healthcare.
GORE™ AME-Clamp is protected by US patent number 7,137,611.
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