Gateway Analytical
Gateway Analytical is a full-service, FDA-registered, DEA-licensed, cGMP-compliant laboratory dedicated to supporting pharmaceutical, biotechnology, and medical device industries. With over a decade of expertise, they offer comprehensive analytical testing services including method development, validation, extractables and leachables testing, container closure integrity testing, particulate analysis, and advanced chromatography. Their mission is to ensure product safety, regulatory compliance, and support innovation through reliable and precise analytical solutions. They are recognized for their excellence by agencies such as the FDA, DEA, ISO, Health Canada, and EMA, and provide tailored services across all stages of drug development, from early-phase research to commercial manufacturing.
Industries
Nr. of Employees
small (1-50)
Gateway Analytical
Gibsonia, Pennsylvania, United States, North America
Services
Full E&L programs including extraction, screening, identification, quantification, materials characterization, and regulatory reporting for packaging, single‑use systems, and device components.
Deterministic, non‑destructive CCIT services and method validation using vacuum decay, HVLD (microcurrent), laser headspace O2/CO2 analysis, and other deterministic methods for vials, syringes, cartridges, bags, pouches and drug‑device assemblies.
Volatile, semi‑volatile, and non‑volatile screening and structural elucidation workflows for extractables and unknowns using GC‑MS and LC‑MS platforms.
Tailored method development across LC‑MS/MS, QTOF, and GC‑MS systems with validation activities performed in accordance with ICH Q2(R2) criteria.
LC‑MS/MS R&D and method transfer workflows to detect and quantify nitrosamines and other genotoxic impurities to support risk assessment and regulatory filing readiness.
Development of LC‑MS/MS‑based workflows for detection and quantification of PFAS in packaging and contact materials.
Full E&L programs including extraction, screening, identification, quantification, materials characterization, and regulatory reporting for packaging, single‑use systems, and device components.
Deterministic, non‑destructive CCIT services and method validation using vacuum decay, HVLD (microcurrent), laser headspace O2/CO2 analysis, and other deterministic methods for vials, syringes, cartridges, bags, pouches and drug‑device assemblies.
Volatile, semi‑volatile, and non‑volatile screening and structural elucidation workflows for extractables and unknowns using GC‑MS and LC‑MS platforms.
Tailored method development across LC‑MS/MS, QTOF, and GC‑MS systems with validation activities performed in accordance with ICH Q2(R2) criteria.
LC‑MS/MS R&D and method transfer workflows to detect and quantify nitrosamines and other genotoxic impurities to support risk assessment and regulatory filing readiness.
Development of LC‑MS/MS‑based workflows for detection and quantification of PFAS in packaging and contact materials.
Expertise Areas
- Extractables & leachables testing
- Container closure integrity testing (CCIT)
- Method development and validation (ICH Q2(R2))
- Small molecule impurity profiling and assay development
Key Technologies
- High‑resolution QTOF mass spectrometry
- Triple quadrupole LC‑MS/MS
- GC‑MS (headspace and direct injection)
- ICP‑MS (via qualified partners)
News & Updates
Gateway Analytical is your go-to laboratory for CCIT of drug products stored at extremely low temperatures. Several regulatory agencies have reviewed our validated methods, and will work for your needs. Contact Gateway Analytical today to learn more about our approach to CCIT for storing cryogenically stored products.
Trust Gateway Analytical to guide your biopharmaceutical products towards meeting and exceeding safety standards. Gateway Analytical provides comprehensive testing services aligned with the United States Pharmacopeia (USP) chapters <661>, <661.1>, <661.2>, and <665>. These guidelines are crucial for ensuring the safety and suitability of plastic systems, components and materials used in the manufacturing process of pharmaceutical drug substances (DS) and drug products (DP).
Gateway Analytical is your go-to laboratory for CCIT of drug products stored at extremely low temperatures. Several regulatory agencies have reviewed our validated methods, and will work for your needs. Contact Gateway Analytical today to learn more about our approach to CCIT for storing cryogenically stored products.
Trust Gateway Analytical to guide your biopharmaceutical products towards meeting and exceeding safety standards. Gateway Analytical provides comprehensive testing services aligned with the United States Pharmacopeia (USP) chapters <661>, <661.1>, <661.2>, and <665>. These guidelines are crucial for ensuring the safety and suitability of plastic systems, components and materials used in the manufacturing process of pharmaceutical drug substances (DS) and drug products (DP).