Particulate Risk Investigation and Root-Cause Resolution
Container Closure and Product-Package Integrity
- Cryogenic Packaging & Transport Simulation Studies
- Vacuum Decay Studies
- MicroCurrent High Voltage Leak Detection (HVLD)
- Laser-Based Gas Headspace Analysis
- Vials, Syringes, Cartridges, & Difficult Configurations
- Custom Method Development and Validation Across Multiple Platforms
- “Which CCIT Method Fits My Package?” use-case page
Visible & Subvisible Particle Characterization: Beyond Compendial Counts
Parenteral Packaging Functional Suitability
Biologics & Protein Therapeutics
Flow Imaging Microscopy (FIM/MFI) and orthogonal testing to instantly separate protein aggregates from silicone oil and foreign debris. By tracking particle morphology across formulation and packaging changes, we give you the technical clarity to de-risk development and satisfy regulatory scrutiny.
Sterile Injectables & Parenteral Manufacturers
Gateway delivers rapid, definitive particulate identification, complaint investigation support, and root-cause resolution alongside cGMP USP particulate testing to keep your operations moving. Paired with deterministic Container Closure Integrity Testing (CCIT) and USP <382> functional suitability evaluations.
Advanced Therapies (Cell & Gene Therapy)
Gateway specializes in low-volume particulate investigations, single-use component evaluations, and cryogenic container performance studies tailored to this evolving regulatory landscape.
Solving Drug Product Risks with Gateway Analytical. Applying Lifecycle Quality Risk Intelligence.
At Gateway Analytical, we apply Lifecycle Quality Risk Intelligence to connect analytical evidence across your entire product journey—combining rapid root-cause particulate identification, deterministic container closure integrity, subvisible particle characterization, and functional suitability testing.
By translating isolated laboratory data into long-term product understanding, we give your quality, operations, and regulatory teams the technical clarity and scientific proof needed to mitigate risk, resolve deviations, and release product with total confidence.
Technical Documentation & Resources
Connecting Analytical Evidence Across Your Drug Product Journey
By bridging our four core service areas: Particulate Investigations, Container Closure Integrity, Subvisible Characterization, and Functional Suitability—we transform routine laboratory data into deep product understanding, investigation readiness, defect prevention, and total regulatory confidence.
Beyond One-Off Testing: Lifecycle Quality Risk Intelligence
Protein Testing with Flow Imaging Microscopy (FIM) Confidence Micro Flow Imaging (MFI)
Precision Analytical Testing for Proteins Using Micro Flow Imaging (MFI) | Flow Imaging Microscopy (FIM)
Protein Testing with Flow Imaging Microscopy (FIM) / Micro-Flow Imaging (MFI) from Gateway Analytical bridges the critical insight gap. By combining high-resolution image capture with automated morphological analysis, the team at Gateway Analytical transforms simple numerical counts into actionable scientific clarity. Our specialized testing packages and equipment, powered by FlowCam empowers sponsors to characterize subvisible particle populations, trace aggregate origin, and make confident, data-driven decisions across every phase of the product lifecycle.
Gateway Analytical: Your Partner in Precision
Gateway Analytical builds fit-for-purpose FIM testing strategies tailored to your product and risk profile. We leverage method development to cater to your specific submission, delivering representative count/size data, images, and particle properties, supporting early development, comparability, and late‑stage investigations.
- Flow Imaging Microscopy (FIM) techniques from Gateway Analytical enable comprehensive particle characterization based on morphology & key properties, including circularity, edge gradient, and aspect ratio.
- We pair flow imaging with independent FTIR/Raman spectroscopy and visible particulate testing to cross-verify morphology with chemical composition, providing definitive particle identification.
- Application‑specific testing for real‑world stress conditions.
- We apply FIM in freeze–thaw, agitation, shipping simulation, and stability studies, directly linking particle formation to manufacturing, handling, and container–closure interactions.
- Characterization of subvisible particles in protein therapeutics
- Microencapsulation formulation and quality control
- Characterization of dry active pharmaceutical ingredients (API’s), fillers, and excipients
- Supporting early development, comparability, and late‑stage investigations.
- cGMP-Compliant Laboratory
- FDA Registered & Inspected
- Health Canada Inspected
- EMA Inspected
- 21 CFR Parts 210 & 211
- 21 CFR part 820
- ISO/IEC 17025:2017 Accredited
- ISO 9001:2015 Accredited
- DEA Drug Schedule II, III, IV, & V licensed
- Recognized Leader in PDA Community
Analytical Intelligence Hub
Advancements in High-Resolution Mass Spectrometry
- Flow Imaging Microscopy (FIM) techniques from Gateway Analytical enable comprehensive particle characterization based on morphology & key properties, including circularity, edge gradient, and aspect ratio.
- Paired with independent FTIR/Raman spectroscopy and visible particulate testing to cross-verify morphology with chemical composition, providing definitive particle identification.
Implementing AI in Automated Sample Assay Workflows
- We apply FIM in freeze–thaw, agitation, shipping simulation, and stability studies, directly linking particle formation to manufacturing, handling, and container–closure interactions.
- Application‑specific testing for real‑world stress conditions.
Next-Generation Sequencing for Precision Medicine
- Microencapsulation formulation and quality control
- Characterization of dry active pharmaceutical ingredients (API’s), fillers, and excipients
- Supporting early development, comparability, and late‑stage investigations.
- Characterization of subvisible particles in protein therapeutics
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.