Pharmaceutical & Biopharmaceutical Industry
In a highly regulated industry marked by economic pressures and drug development and processing challenges, Gore provides technology-driven products and process components designed for efficiency, reliability and contamination control.
Enhancing Drug Delivery and Manufacturing with Reliable Solutions
Advancements in drug discovery are driving innovative treatments and disease prevention at an accelerating pace. With these breakthroughs comes a heightened need for security—ensuring pharmaceutical products meet strict safety regulations through careful manufacturing and packaging.
Gore supports both drug discovery and manufacturing with reliable solutions for purifying, transferring, storing, filtering, processing, and packaging. Our durable, multi-use components and single-use products help control costs and improve processes, a critical factor in the rising expense of biologics development.
With expertise in materials science and a strong commitment to regulatory compliance, we have a proven track record of enhancing pharmaceutical processing and delivery.
Gore’s advanced materials are clean, well-characterized and uniquely suited for biosciences applications.
Innovative Solutions for Biologic Drug Packaging and Processing
Modern biologic drugs demand equally advanced packaging solutions, especially for silicone-sensitive formulations. The GORE® IMPROJECT® Plunger for pre-filled syringes (PFS) is designed for bare glass (non-siliconized) or polymer barrels and is silicone-free*†—neither in raw materials nor manufacturing. By eliminating silicone, it helps prevent aggregation and particulation while ensuring consistent drug delivery over time. Its proprietary design and fluoropolymer barrier also prevent significant extractable compounds.
For decades, Gore has leveraged its expertise in fluoropolymers to develop cutting-edge solutions for pharmaceutical and biopharmaceutical applications.
Eliminate silicone in both barrel and plunger to protect sensitive biologics in PFS.
Advancing Pharmaceutical Manufacturing with ePTFE Technology
In the early 2000s, Gore introduced the GORE® LYOGUARD® Freeze-Drying Tray, designed with an ePTFE membrane for superior vapor transmission. This single-use tray enables rapid freeze-drying while minimizing operator exposure to active pharmaceutical ingredients (APIs) and reducing cleaning and validation costs.
Building on this success, Gore expanded its portfolio with solutions that enhance drug substance protection and process efficiency:
- GORE® STA-PURE® Flexible Freeze Containers: Designed for bulk drug storage and transport, these high-purity fluoropolymer containers offer exceptional crack- and impact-resistance during cold chain handling while maintaining a low extractables profile.
- GORE® STA-PURE® Pump Tubing: Ensures durable, reliable performance in high-pressure and long-run processing conditions.
- GORE® Molded Assemblies: Provides secure liquid transfer, containment, and sampling in pharmaceutical manufacturing.
Single-use, enclosed freeze-drying trays that keep product in the tray during the lyophilization process.
GORE STA-PURE Pump Tubing performs reliably under challenging processing conditions.
High-Performance Filtration and Protein Purification
GORE® Protein Capture Devices are ideal for drug discovery applications, providing high binding capacity and short residence times.
As the industry sought quality and process improvements, Gore applied its expertise in filtration and venting to develop proven solutions:
- GORE® Microfiltration Media: Integrated into filter devices for highly effective particle retention, ensuring superior process efficiency and security.
- GORE® Protein Capture Device with Protein A: Designed for biologic drug research, this device features a unique membrane that enables faster antibody purification, reducing pipeline bottlenecks and eliminating downstream concentration steps for improved efficiency.
With decades of experience in material science, Gore continues to drive innovation, helping pharmaceutical and biopharmaceutical manufacturers enhance process reliability and drug safety.
Products that Perform as Promised
With Gore’s materials science expertise and collaboration with the pharmaceutical industry comes 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 13485, ISO 15378, and/or regulations for food contact.
* Not including needles or tip caps
† Silicone oil not intentionally added to raw materials or process for manufacturing plunger.