When Quality Control (QC) identifies an unknown particle during fill-finish or inspection, it isn’t just a deviation, it’s a critical event. For developers of CGT, ATMPs, and LNP-based therapies, the stakes are even higher. These findings require specialized technical oversight to distinguish intrinsic, product-related aggregates from extrinsic, extraneous contaminants.
Resolving a batch hold and protecting your filing timeline requires more than a “test result”; it requires chemical identification that withstands regulatory scrutiny. Gateway Analytical provides the scientific authority required to resolve these investigations. Our Ph.D.-led team moves beyond standard pass/fail to deliver definitive identification and actionable root-cause insight.
Analytical Workflows for Forensic Investigations
We leverage a specialized suite of instrumentation specifically configured to deliver regulator-ready reports for complex matrices:
- LC-MS/MS & QTOF-MS: We provide precise chemical identification of unknown compounds and characterization of reactive byproducts where standard chromatography fails.
- GC-MS: We pinpoint volatile and semi-volatile extractables, identifying the specific chemical contributors to particulate formation.
- SEM-EDS & Micro-Raman Spectroscopy: We deliver high-resolution morphological and chemical characterization to distinguish between visible and subvisible particles at the source.
Contamination Tracing & Regulatory Defense
A pass/fail result is rarely enough to satisfy a deep-dive BLA review or a Pre-Approval Inspection (PAI). Gateway provides the analytical depth to pinpoint the exact source of a deviation—ensuring your investigation package survives governance and demonstrates a total command of your particulate control strategy.
Do not let an unidentified particle escalate into a prolonged disruption. Trust Gateway Analytical for immediate, expert support. Reach out today for a priority consultation:
📞 (724) 443-1900 | ✉️ in**@***************al.com
