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.
Forensic Particulate Investigations: Navigating Quality Control Obstacles
When Quality Control (QC) identifies an unknown particle during fill-finish or inspection, the deviation represents a critical path event. For developers of CGT, ATMPs, and
Closing the USP <1790> Gap: Demonstrating Inspection Adequacy for DIPs
As we face the new regulatory landscape of 2026, standard 100% visual inspection is no longer sufficient to meet regulatory scrutiny. During a BLA review
The Gateway Analytical Journal – Monthly Roundtable – Issue 01 // January 2026
Welcome to the Gateway Analytical Monthly Technical Briefing! Every month, we’ll bring you the latest on evolving regulatory expectations, upcoming industry events, and key insights
Beyond Compliance: Navigating the Future of USP <382> and <661>
With the 2025 regulatory deadlines now firmly established as the baseline, 2026 represents a shift from compliance to system-level optimization. For organizations developing and manufacturing
USP <382> Is Now in Effect. Here’s What Your Team Needs to Do Next.
As of December 1, 2025, USP <382> is officially in effect and teams across the industry are now navigating the requirements for system-level functional suitability
Are Your Drug Products Ready for the December 1st, 2025 USP <661> Deadline?
The clock is ticking! The compliance deadline for USP <661.1> and <661.2> is approaching quickly, and every day truly matters. These crucial updates are set
Key Takeaways & FAQs from Our Webinar: USP <382> Deadline Readiness
With the USP <382> deadline still fast approaching on December 1, 2025, our recent webinar made one thing clear: teams are taking action. The urgency
USP <382> December Deadline. Compliance Starts Here
Last call to secure your seat today! Get ahead of upcoming regulatory deadlines! Join Gateway Analytical tomorrow, October 21st for our exclusive webinar, where we
*Upcoming Webinar* USP <382> & Annex 1: Converging Standards for Sterile Packaging Compliance
Save your spot today and gain a roadmap to compliance and inspection readiness. Join our webinar on Tuesday, October 21, 2025, where our experts from
Unknown Particles? High-Stakes Drug Products? Start Here.
When an unidentified particulate appears during fill or final inspection, timelines stall, compliance is at risk, and your team feels the pressure. In critical moments
Discoloration in Your Drug Product? Find Out Why, Fast.
It’s Not Just a Color Shift. It’s a Chemical Clue. A sudden color change in your gel, injectable, or cream isn’t cosmetic, it’s often an
It’s Not Just a Color Shift. It’s a Chemical Clue. Submit Your Sample for Root Cause Analysis!
A sudden color change in your gel, injectable, or cream isn’t cosmetic, it’s often a sign of chemical instability or packaging interaction. Whether it’s API
Don’t Just Blame the Formulation, Investigate the Interaction
Is Your Drug Formulation Reacting with the Bag? Unexpected Precipitate or Haze? It Might Be the Container. Visual or chemical instability doesn’t always start with
Proteinaceous Particle in Your Fill Line? Here’s What to Do Next
Unknown Particulate? High-Risk Batch? No Time to Wait. When a proteinaceous particle appears during fill, inspection, or within the final container, it signals more than
Early-Phase Development
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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.