As PDA Week 2026 comes to a close, our team is returning from Denver energized by the insights, conversations, and collaborations we shared with global leaders in pharmaceutical science, sterile manufacturing, and regulatory innovation. This year marked the 80th anniversary of the PDA in the U.S., making the event both a milestone celebration and a forward-looking forum on the future of product quality.
Our Unified Approach to Drug Delivery & Analytical Defensibility
We were proud to showcase how combining advanced elastomeric closure components with robust analytical strategies strengthens both product performance and regulatory confidence alongside our parent company Aptar Pharma. Throughout the week, discussions centered on how developers can proactively address particulate and CCI risks across increasingly complex delivery systems.
Key focus areas included:
Visible Particulate Characterization
Attendees explored investigative workflows for identifying unknown particulates using SEM-EDS and micro-Raman — crucial for batch-release confidence and for resolving high-risk events.
Subvisible Particle Testing for Emerging Modalities
Teams working with biologics, LNPs, CGT products, and mRNA therapies engaged in deep discussions on low-volume method verification, USP <788>/<787> strategies, and establishing scientifically appropriate bridges for new modalities.
Container Closure Integrity (CCI) Strategies for Complex Systems
With delivery platforms evolving rapidly, visitors were eager to learn how CCI testing integrates into system-level optimization and long-term risk mitigation.
Technology Lab Demonstrations: A Hands-On Look at Advanced Tools
Our live Technology Lab sessions, delivered in partnership with Lighthouse Instruments and PTI, provided attendees with a firsthand look at the CCI and inspection technologies shaping the next generation of compliant, cGMP-aligned testing strategies.
These demonstrations highlighted how leading developers leverage these tools to:
· Improve detection sensitivity for DIPs (Difficult-to-Inspect Products)
· Strengthen risk-based particulate and CCI assessments
· Replace operator-dependent inspection steps with instrument-driven confidence
· Generate defensible data packages that align with tightening global expectations
Themes That Defined PDA Week 2026
Across hundreds of conversations, several themes stood out:
· Regulatory expectations are accelerating faster than ever
· Scientific defensibility, not minimum compliance, is the new standard
· Complex modalities demand new approaches to particulate and CCI challenges
· Integrated device–analytics strategies are essential for de-risking development
We appreciated every opportunity to help teams think through next-steps for their 2026 programs.
Let’s Continue the Conversation
Thank you to everyone who visited us in Denver, whether at the booth, the Technology Lab, or in one of the conference sessions. We look forward to building on the connections made throughout the week.
If you were unable to attend, or if you’d like to continue discussing your particulate or CCI strategy:
in**@***************al.com (724) 443-1900
Now is the ideal time to prepare your analytical roadmap for 2026.
Gateway Analytical — Scientific Clarity for Complex Problems.
