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 LNP-based therapies, these findings require specialized technical oversight to distinguish product-related aggregates from extraneous contaminants. Resolving a batch hold requires chemical identification that withstands global regulatory scrutiny.
Gateway Analytical provides the scientific authority required to resolve these investigations. Our Ph.D.-led team uses advanced chromatography and microscopy to provide definitive identification and root-cause insight.
Analytical Workflows for Particulate Investigations: We leverage a specialized suite of instrumentation to deliver regulator-ready reports:
LC-MS/MS & QTOF-MS: Utilized for the chemical identification of unknown compounds and characterization of reactive byproducts.
GC-MS: Utilized to identify volatile and semi-volatile extractables contributing to particulate formation.
SEM-EDS & Micro-Raman Spectroscopy: Utilized for the morphological and chemical characterization of both visible and subvisible particles.
Contamination Tracing: We provide the analytical depth to pinpoint the source of the deviation, ensuring your data survives governance and inspection.
Do not let an unidentified particle escalate into a prolonged disruption. Trust Gateway for immediate, expert support. Reach out today for a priority consultation:
📞 (724) 443-1900 | ✉️ in**@***************al.com
