Visual or chemical instability doesn’t always originate in the drug itself—often, the container is part of the problem. This is especially true in biologics and cell therapies, where even subtle incompatibilities can lead to haze, particulates, or degradation. These interactions signal more than just a deviation; they point to packaging complexities that require specialized forensic insight.
Gateway Analytical helps companies overcome these complex regulatory and compliance demands. Our chromatography experts investigate formulation and container interactions using advanced methodologies, including LC-MS/MS, GC-MS, and QTOF-MS. We uncover leachables, degradation products, and reactive byproducts to confirm root cause with precision. This Ph.D.-led oversight ensures your data stands up to regulatory scrutiny, providing the scientific authority required to preserve product integrity and keep your program on its high-potential trajectory.
Our goal is more than a test result. We explain what the findings support, what remains uncertain, and where additional evidence may be needed. That understanding supports root-cause determination and helps your team make scientifically defensible decisions about further testing, packaging changes, and product-quality risk.
Ready to fast-track your analytical investigations? Reach out today for a priority consultation:
📞 (724) 443-1900 | ✉️ in**@***************al.com
