In the production of pharmaceuticals, patient safety must come first.

Overview

Pharmaceutical and biopharmaceutical processing

Specifically designed for used in pharmaceutical environments, Gore’s products and process components are designed for efficient processing and pure results.

Through developments in drug discovery, the industry is finding new, innovative ways to treat and even prevent diseases. Not only does the pace of research and discovery continue to quicken, with these new possibilities for patient well-being comes greater need for security: To ensure pharmaceutical products are safe for patients, they must be manufactured and packaged to minimize risk to the user as required by stringent regulations.

Gore helps those in both drug discovery and manufacturing compete in this increasingly regulated landscape with reliable solutions for purifying, transferring, storing, filtering, processing and packaging. These solutions include durable, multi-use process components and single-use products that enable researchers and manufacturers to control costs through process improvements — highly important given the escalating costs of biologics development.

Backed by our materials science expertise and commitment to regulatory compliance, we have a track record of improving the processing and delivery of pharmaceutical products.

Meeting the Industry’s Changing Needs

As an expert in fluoropolymers, Gore has contributed technology-driven solutions for many industries. In the early 2000’s, we saw an opportunity to contribute to the pharmaceutical industry with the release of the GORE® LYOGUARD® Freeze-Drying Tray.

GORE LYOGUARD Freeze-Drying Tray

The breathability of ePTFE gives GORE LYOGUARD Freeze-Drying Trays its superior vapor transmission rate.

The single-use tray incorporates an ePTFE membrane selected for its superior barrier properties and high vapor transmission rate. The tray’s high vaporization rate allows materials to freeze-dry very quickly — while its barrier protection minimizes the risk of cross-contamination. As a single-use solution, the tray delivers maximum quality in minimal processing time.

Loading a WM pump with tubing

GORE STA-PURE Pump Tubing performs reliably under challenging processing conditions.

Over time, we’ve added more transfer and containment solutions to our portfolio, leveraging our materials science expertise and additional ePTFE benefits, like its biocompatibility, high tensile strength and low particulation.

GORE® STA-PURE® Pump Tubing provides durable and reliable product performance under high pressure or other challenging process conditions. Our other single-use components, such as GORE™ Molded Assemblies, enable the secure transfer, containment and sampling of liquids during pharmaceutical manufacture.

GORE® STA-PURE® Gasketing Products are the only fully documented flange-gasketing products that meet the requirements of the most demanding pharma and food processing requirements, such as biocompatibility and U.S. and EU Food Contact Compliance.

As the industry sought quality and process improvements, Gore leveraged its decades of experience in filtration and venting to serve pharmaceutical and biopharmaceutical manufacturers. Now, we offer several proven products for filtration:

GORE® Microfiltration Media is readily incorporated into filter devices.  Our various forms of filter media offer effective and reliable retention of particles to provide superior efficiency and process security.

For companies engaged in large-scale food, feed and industrial fermentation processes, GORE® Fermentation Air Filters are drop-in replacement cartridges that combine high retention with high airflow and low pressure drop across the filter — allowing companies to save energy and potentially boost yields.

GORE® Sterilizing-Grade Vent Filters are the smallest, lightest solution for maximizing bi-directional flow of air and gases in small-scale sterile filtration and venting applications. The filters’ small size and weight make them resistant to errors like tube kinking, while their airflow rates are equal to much larger filters.

GORE Sterlizing-Grade Vent Filter

GORE® Sterilizing Grade Vent Filters (right) offer the airflow of other commercially available 50 mm vent filters — but in a smaller, lighter-weight package.

GORE Protein Capture Devices in two sizes

GORE™ Protein Capture Devices are ideal for drug discovery applications, providing high binding capacity and short residence times.

Researchers in the fast-growing biologics drug development depend on repeatable and reliable processes to deliver high quality results. Traditional protein purification processes can be slow and often require additional steps to achieve needed concentration.

The GORE™ Protein Capture Device with Protein A utilizes a unique membrane solution for faster antibody purification to help minimize screening pipeline back-ups, help eliminate downstream concentration steps, and improve the speed of purification.

Products that Perform as Promised

With Gore’s materials science expertise and collaboration with the pharmaceutical industry come an understanding of how our solutions provide value in a given application.

When developing a product or process component, we tailor our materials and performance targets to suit the customer’s system requirements, often going beyond what’s expected. Prior to releasing the product, we rigorously test it for application-readiness to ensure peak performance and reliability over time.

Good Manufacturing Processes

All Gore products for life sciences are manufactured specifically for use in medical or pharmaceutical settings and comply with regulations our customers may require. Depending on those requirements, you will find products manufactured under Good Manufacturing Practices (GMP), ISO 9001, ISO 13485, ISO 15378, and/or regulations for food contact.