Press Releases
Curiosity + Expertise = Innovation.
Catch up on all the latest Gateway Analytical news and press releases, see a list of events we’ll be attending, and read our original content discussing our latest services offerings and instruments in the articles below.
Examining the Intricacies of Particulate Matter Analysis in Pharmaceuticals
The characterization and analysis of particulate matter are critical processes that ensure product quality and patient safety. Once isolated, particulate matter is first observed under
What Changes Are Happening to USP <382> in December 2025?
In December 2025, significant changes will impact injectable and parenteral developers, as well as CMO/CROs, when USP <382> Elastomeric Component Functional Suitability in Parenteral Product
Particulate Matter Characterization in Pharmaceuticals
Characterizing particulate matter in pharmaceuticals is critical for ensuring product quality, regulatory compliance, and patient safety. This complex process requires advanced analytical techniques to precisely
Understanding the Scope and Impact of USP <382> on Pharmaceutical Packaging and Delivery Systems
USP <382> Pharmaceutical Packaging: Ensuring Safety and Integrity When it comes to pharmaceutical packaging, meeting compliance standards isn’t optional—it’s essential for ensuring product safety and
Mastering Source Determination: A Critical Step in Particulate Matter Control for Therapeutic Development
When it comes to therapeutics development, particularly for cellular therapies, managing particulate matter contamination is crucial. Source determination is an essential component of an effective
Wishing You Very Happy Holidays from Gateway Analytical!
Looking Ahead: Participation in Key Industry Events As 2025 quickly approaches, we round out another incredible year at Gateway Analytical. From our participation this year
Source Identification: Particulate Matter Control Solutions for Pharmaceuticals
In our industry, controlling particulate contamination is critical to ensuring product quality and patient safety. The field of forensic trace evidence analysis, known for its
Exploring Functional Suitability & Package/Delivery System Integrity (USP 382 & USP 1207)
Container closure integrity (CCI) is a critical focus for regulatory agencies, demanding rigorous standards for ensuring the safety and efficacy of your injectable and parenteral
Particulate Matter in Cell Therapies: A Critical Step Forward
Cell therapy developers have reached a pivotal moment where implementing a particulate control strategy is no longer optional but essential for future success. Particulate matter
Gateway Analytical at CPHI Europe 2024 & PDA Universe of Pre-Filled Syringes & Injection Devices Conference 2024 – Recap and Highlights
In October, Gateway Analytical was thrilled to attend two premier conferences around the globe. Our team of analytical experts had the opportunity to present at
Quality and Safety in Pharmaceutical & Medical Device Testing
Leading the Industry in Quality, Safety, and Compliance Gateway Analytical excels in ensuring top-tier quality and safety for pharmaceutical products and medical devices on their
Gateway Analytical: Pioneering Glass Delamination Solutions
Glass Delamination in pharmaceutical packaging represents a substantial risk that could potentially compromise product safety and efficacy. This phenomenon, characterized by the flaking or peeling
Particulate Analysis: Our Commitment to Safety & Efficacy
Ensuring the purity and safety of pharmaceutical products is paramount, as even trace amounts of particulate matter can pose significant health risks. Gateway Analytical’s Particulate
Unveiling CCIT: A Gateway Analytical Spotlight
When it comes to pharmaceuticals; container closure integrity is not just a quality control measure; it’s about patient safety. Gateway Analytical’s spotlight on Container Closure
Early-Phase Development
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables

Empowering Your Journey Toward Enhanced Patient Care
Covering every stage of the drug development journey with our state-of-the-art, FDA-inspected, cGMP-compliant facilities designed to minimize bottlenecks and maximize success.