Particle Morphology Assessment

Illustration of particle morphology assessment (AI generated)

Particle morphology assessment is vital in the pharmaceutical industry, especially for protein-based biopharmaceuticals like monoclonal antibodies and therapeutic proteins. It involves analyzing the physical characteristics of particles, such as size, shape, and surface features, which can impact product stability, efficacy, and safety. For instance, particles can lead to aggregation, reducing a drug's effectiveness, or trigger immune responses, posing risks to patients.

STEMart specializes in using advanced optical and microscopy imaging techniques to provide comprehensive analysis. This helps ensure your biopharmaceutical meets regulatory standards and performs optimally, addressing potential issues early in development to save time and costs.

Our Services and Techniques

Technique	Principle	Size Range	Application
Microflow Imaging (MFI)	Uses digital microscopy to capture real-time images of particles in flow	1-400 μm	Detects and characterizes subvisible particles, especially transparent aggregates, aiding in quality control.
Electron Microscopy	Uses electrons for high-resolution imaging (SEM for surfaces, TEM for internals)	Nanometer to micrometer	Provides detailed shape, size, and composition analysis, crucial for small or complex particles.
Confocal Laser Scanning Microscopy	Creates 3D images using laser light via optical sectioning	Varies by setup	Visualizes internal structures and studies particle interactions, useful for co-localization studies.
Fluorescence Microscopy	Uses fluorescent labels to visualize specific components under excitation	Varies by setup	Identifies particle types and studies interactions, enhancing understanding of distribution.

Each technique is selected based on the sample's needs, ensuring comprehensive analysis. For instance, MFI is particularly effective for detecting transparent protein aggregates, which are often missed by other methods, as highlighted in studies on biopharmaceutical formulations. Electron microscopy, including SEM and TEM, offers unparalleled resolution for detailed morphological characterization, essential for regulatory compliance and product development.

Process Overview

Illustration of our particle morphology assessment process (STEMart Original)

Initial Assessment: We evaluate the sample to choose the best techniques.
Characterization: We perform the selected imaging to characterize particles.
Data Analysis: Our experts analyze data and compile a detailed report.
Reporting: You receive a comprehensive report with findings and recommendations.

Why Choose Us

Expertise: Our team has extensive experience in pharmaceutical testing, particularly for protein-based biopharmaceuticals.
State-of-the-Art Facilities: We use the latest microscopy systems for accurate results.
Comprehensive Services: From preparation to reporting, we cover all needs.
Regulatory Compliance: Our methods meet or exceed industry standards.
Customized Solutions: We tailor services to your specific challenges.

This combination of expertise, technology, and client-focused service positions us as a leader in particle morphology assessment for biopharmaceuticals, ensuring you receive the highest quality support for your development and manufacturing needs.

Particle Morphology Assessment

Our Services and Techniques

Process Overview

Why Choose Us

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