Protecting Drug Products. Preserving Patient Safety.
At Gateway, we employ advanced analytical techniques to evaluate contaminants that often migrate from packaging or device materials into drug products. These studies are crucial for identifying potential risks and ensuring product safety throughout its lifecycle.
For more than 15 years, Gateway Analytical has remained a trusted leader in analytical testing, specializing in USP-compliant Extractables & Leachables (E&L) studies. These services play a vital role in safeguarding drug product integrity, patient safety, and regulatory compliance, foundational pillars in the pharmaceutical and medical device industries.
Our expertise extends far beyond routine studies. We support urgent investigational needs—such as unknown particles, formulation discoloration, or packaging reactivity with priority sample testing, Ph.D.-led analysis, and regulator-ready reports. Whether you’re facing a batch hold due to a visible particle or seeing unexpected chemical interactions with your container system, Gateway delivers.
E&L Investigational Testing: Fast, Focused, and Defensible
When a visible or subvisible particle shows up during fill, inspection, or stability testing, it’s not just a quality concern, it’s a regulatory crisis. Gateway specializes in:
- Rapid identification of proteinaceous or foreign particles
- Root-cause investigation of discoloration, haze, or precipitate
- Compatibility analysis between drug products and packaging materials
Our scientists utilize advanced E&L instrumentation, including LC-MS/MS, TOF, and GC-MS, to get to the root of the issue—fast. We don’t just generate data; we provide clear answers that support QA, CMC, and batch release decisions.
Adopting a lifecycle approach is essential for the successful development and manufacturing of cell therapies. Explore how Gateway Analytical can support your journey to market. With over a decade of expertise in parenteral testing, we cover a broad range of services from process and formulation development, product-package validation, clinical & commercial manufacturing, to visual inspection, quality control, and release testing. Reach out to our experts at (724) 443-1900 or info@gatewayanalytical.com, or feel free to visit our contact page to connect with us!
