For novel modalities and complex injectables, a “templated” particulate control strategy is a regulatory liability. In 2026, applying standard USP <788> logic to a non-standard formulation, without accounting for unique physical properties or delivery systems, is often viewed as a gap in scientific understanding during BLA or PAI reviews.
Gateway Analytical provides a Non-Standard Formulation Control Strategy Review to move programs from passive compliance to proactive governance. We specialize in the intersection of drug formulation and primary container, particularly where standard methods are inadequate. Our strategic review focuses on:
Physical Property Accounting: Defining how turbidity, high concentration, or complex delivery systems impact particulate detection.
Method Defensibility: Selecting and justifying the analytical path (e.g., Method 1 vs. Method 2) before it becomes a deviation.
Lifecycle Risk Reduction: Building a control plan that accounts for the interaction between formulation and primary container.
When standard methods aren’t scientifically defensible, a custom control strategy is the only path to filing robustness.
Curious about next steps? Interested to learn more about our process and toolkit at Gateway Analytical? Schedule your call, or use our Interactive Sample Submission Form here: https://gatewayanalytical.com/contact-us/
Gateway Analytical — Scientific Clarity for Complex Problems.
