Early Biologics Support
Supporting Regulatory-Driven Excellence in Pharmaceutical and Medical Device Testing
Gateway Analytical delivers exploratory workflows using high-resolution QTOF-MS for peptide-based biologics, supporting digestion-based structural comparisons, sequence confirmation, and impurity tracking. These workflows offer detailed molecular insights critical for early development and comparability studies.
As part of our expanding capabilities, offerings include host cell protein (HCP) profiling and biologic-specific leachables analysis—ensuring comprehensive support for biologic safety, integrity, and regulatory compliance. Trust Gateway’s scientific depth and regulatory experience to advance your biologic development pipeline.
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.