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 and Biologic Particle Characterization with Flow Imaging Microscopy (FIM)
Gateway Analytical characterizes subvisible particles in proteins and biologics using Flow Imaging Microscopy, particle morphology, and complementary analytical methods.
Protein therapeutics and other biologics can contain complex particle populations that concentration and size data alone may not fully explain. We use Flow Imaging Microscopy to generate particle images, morphological measurements, and population-level data that support formulation development, stability studies, comparability assessments, and product quality investigations.
Why Proteins and Biologics Require Deeper Particle Insight
Subvisible particles in protein products may be associated with several potential sources or mechanisms, including:
- Protein aggregation
- Silicone oil
- Tungsten residues
- Packaging components
- Product-contact materials
- Manufacturing processes
- Handling and agitation
- Temperature exposure
- Freezing and thawing
- Storage conditions
- Foreign or extrinsic matter
For your drug product, a compendial particle count may be necessary for release or stability testing, but that count alone generally doesn’t determine particle composition or explain why the population changed. Leveraging Flow Imaging Microscopy, Gateway Analytical develops images and morphological data that help you examine particle populations more closely.
Particle counts can reveal that something changed. Particle images may help explain how.
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.
Formulation Development
Compare particle populations across formulation conditions, excipients, concentrations, or processing parameters
Stability Studies
Evaluate changes in concentration, size, images, or morphology across time points and under storage conditions.
Product-Package Interaction
Investigate particle populations associated with silicone oil, containers, or delivery systems.
Process & Handling Evaluations
Compare samples after agitation, pumping, mixing, filtration, or shipping simulation.
Investigation of Unexpected Results
Use imaging and morphology to determine if particle counts reflect a changing population.
Release and Stability Support
Combine compendial particle-counting with characterization for compliance and deeper understanding.
What Flow Imaging Microscopy Provides
Flow Imaging Microscopy automatically captures images of particles as liquid samples flow through a flow cell. Depending on the study design and instrument capabilities, the resulting dataset may include:
- Particle concentration
- Size measurements
- Particle images
- Shape and morphology measurements
- Population distributions
- Sample-to-sample comparisons
- Lot or stability time point comparisons
- Classification using scientifically justified parameters
Clear Interpretation within Scientific Limits
Flow Imaging Microscopy (FIM or MFI) from Gateway Analytical provides high-quality particle images and morphological information, but image-based classification alone doesn’t establish chemical identity. When you need more specific material identification, we may recommend complementary methods such as:
- Optical microscopy
- Polarized light microscopy
- FTIR spectroscopy
- Raman spectroscopy
- Scanning electron microscopy with energy-dispersive X-ray spectroscopy
- Comparison with reference materials
- Forensic investigation of isolated particles
Particulate & Pharmacuetical Forensics from the Experts
Gateway Analytical builds fit-for-purpose Flow Imaging Microscopy (FIM) testing strategies tailored to your product and risk profile. We love supporting early development, comparability, and late‑stage investigations for leading drug developers and manufacturers .
- Enables comprehensive particle characterization based on morphology & key properties, including circularity, edge gradient, and aspect ratio.
- Application‑specific testing for real‑world stress conditions.
- 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.
Leaders in the Scientific Community
- 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
Discuss Protein Testing Needs with our Experts
- cGMP Compliant & FDA, EMA, DEA Registered Laboratory Facility
- Specialized in Particulate Identification & Material Characterization
Have a complex product-quality question? Let’s define the right analytical path forward.
Gateway Analytical applies pharmaceutical forensics, specialized analytical testing, and expert interpretation to help regulated life science companies understand particulate, package integrity, subvisible particle, and component performance challenges. Contact our team to discuss your next product.