Are you attending PDA Week 2026, the industry’s premier gathering for leaders in sterile manufacturing, pharmaceutical quality, and regulatory science? From March 23-25, Gateway Analytical will join global innovators at the Gaylord Rockies in Denver for one of the most anticipated events of the year.
This year’s program carries special significance as the PDA celebrates its 80th anniversary in the United States and 20th anniversary in Europe — a testament to decades of scientific collaboration and advancement. We are proud to be part of this milestone event and contribute to the conversations shaping the future of injectable product quality.
What We’re Focusing on at PDA Week 2026
As regulatory expectations continue to evolve, development teams face growing pressure to generate scientifically defensible data for complex modalities, newer delivery systems, and Difficult-to-Inspect Products (DIPs). Throughout the week, our team will be discussing analytical strategies that help programs anticipate and overcome these challenges, including:
Visible Particulate Characterization
Identifying and understanding visible particles remains a top regulatory concern. We’ll explore forensic approaches, including SEM-EDS and micro-Raman, that support root-cause investigations and help teams resolve particulate events before they escalate.
Subvisible Particle Testing
From monoclonal antibodies to LNP and mRNA platforms, subvisible particle control is a critical component of product safety. Our team will highlight best practices for USP <788>/<787> testing, low-volume verification, and scientific bridging strategies for emerging modalities.
Container Closure Integrity (CCI) Testing
With delivery systems growing more complex, ensuring closure performance is essential. We’ll showcase how robust CCI testing integrates with particulate strategies to reduce risk across the product lifecycle.
Why Meet with Gateway Analytical in Denver?
PDA Week offers the unique opportunity to engage directly with industry experts and troubleshoot real-world analytical challenges. Whether your focus is regulatory submission preparation, method verification, particulate troubleshooting, or evaluating DIP scenarios, our scientists are ready to support your 2026 roadmap.
Attendees can gain insights into:
· Navigating evolving USP and global regulatory expectations
· Building defensible particulate and CCI testing strategies
· Addressing low-availability sample concerns for new modalities
· Strengthening method verification and system suitability
· Reducing risk and supporting faster, more confident decision-making
Connect With Us at PDA Week 2026 – MARCH 22-25
If you’ll be in Denver, we’d welcome the chance to meet for a strategy session or a 1-on-1 discussion tailored to your analytical challenges and development goals.
To schedule a meeting, please contact us at in**@***************al.com or call (724) 443-1900.
Gateway Analytical — Scientific Clarity for Complex Problems.
