Comprehensive Particulate Analysis
Gateway Analytical provides comprehensive particulate analysis to help identify, characterize, compare, and interpret particulate evidence so teams can understand what the particle is, where it may have come from, whether the issue may recur, and what decision the data can support.
Visible and subvisible particulate matter can create immediate uncertainty for pharmaceutical and biotechnology products, especially sterile injectables, biologics, and advanced therapies where product quality, patient safety, batch release, complaint response, and regulatory confidence may all be affected. Particles may originate from raw materials, manufacturing processes, single-use systems, disposable containers, container-closure components, packaging materials, or product-package interactions.
Gateway Analytical: Your Partner in Precision
At Gateway Analytical, our core mission is to assist pharmaceutical and biotechnology companies in bringing their clinical or commercial drug products to market by leveraging our FDA-registered and inspected cGMP laboratory to rapidly identify foreign particulate matter. For over a decade, we have been industry leaders, offering the fastest turnaround times in the market for foreign particulate matter identification testing. Our dedication to speed and accuracy ensures that our clients can rapidly address particulate concerns, maintaining the highest standards of product quality and patient safety.
The presence of visible and subvisible particulate matter is a critical test in the manufacturing of pharmaceutical and biotechnology drugs. These particles often originate from raw materials, disposable containers, single-use systems, container-closure system components, and are most frequently detected in the final drug products. Given the potential impact of particulate matter on product quality and patient health, it is imperative to effectively identify and eliminate these particles.
Navigating Complexities,
Delivering Clarity
Our services support both routine compliance requirements and complex particulate investigations, including USP <788> Particulate Matter in Injections, USP <790> Visible Particulates in Injections, release testing for USP <787>, USP <788>, and USP <789>, difficult-to-inspect parenteral (DIP) product evaluation, contamination control and source determination, and identification testing for visible particle defects and foreign particulate matter.
By combining compendial particulate testing with advanced particle identification and source-investigation capabilities, Gateway helps teams generate defensible data for batch release, deviation and complaint investigations, contamination control, remediation planning, and regulatory response.
Managing Particulate Matter Challenges
Regulatory bodies have long focused on the issue of particulate matter in drug production. Our approach is informed by a wealth of industry resources, including compendia, guidance documents, technical reports, and publications, ensuring we’re at the forefront of particulate analysis.
At Gateway Analytical, we delve deep into the microscopic world of particulates, transforming the invisible into insights. Our state-of-the-art particulate analysis laboratory empowers pharmaceutical and biotechnological advancements, ensuring your drug products meet the highest standards of purity and safety.
