Optical and Microscopy Imaging Analysis

Optical and Microscopy Imaging Analysis is a cornerstone of pharmaceutical testing, enabling detailed visualization and characterization of samples at the microscopic level. This advanced analytical approach leverages a suite of optical and microscopy techniques to examine the physical and structural properties of pharmaceutical materials, from small particles to complex protein assemblies and solid dosage forms. At STEMart, we provide a robust portfolio of imaging services designed to meet the diverse needs of the pharmaceutical industry.

Our optical and microscopy imaging analysis and its applications diagram. (STEMart Original)

In the pharmaceutical industry, Optical and Microscopy Imaging Analysis serves as an indispensable tool for quality assurance and product development. Its importance lies in its ability to uncover microscopic details that impact the performance and safety of pharmaceutical products. Key benefits include:

Detecting Defects and Impurities: Microscopic analysis identifies subvisible particles, aggregates, surface cracks, or contaminants that could compromise product stability or trigger adverse patient reactions, such as immune responses in biologics.
Ensuring Product Consistency: By characterizing particle morphology, protein structures, and surface features, we help maintain uniformity in formulation and manufacturing processes, directly influencing drug efficacy and bioavailability.
Supporting Regulatory Compliance: Our detailed imaging and comprehensive reporting align with standards set by regulatory bodies like the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and FDA, providing the evidence needed for submissions.
Driving Innovation in Product Development: Insights from microscopy analysis inform formulation optimization, enhance drug design, and address potential issues early, reducing development time and costs.

Our Services

Particle Morphology Assessment

Particle Morphology Assessment focuses on analyzing the physical characteristics of particles such as size, shape, and surface features, within pharmaceutical products, with a particular emphasis on protein-based biopharmaceuticals like monoclonal antibodies and therapeutic proteins. These properties significantly influence product stability, efficacy, and safety.

Protein Structural Visualization

Protein Structural Visualization provides critical insights into the three-dimensional conformation of proteins, a factor that governs their function, stability, and interactions with drug targets. Our Cryo-Electron Microscopy (Cryo-EM) service stands out as a revolutionary tool for high-resolution structural analysis of therapeutic proteins and biologics.

Pharmaceutical Surface Defect Identification

Pharmaceutical Surface Defect Identification ensures the integrity of solid dosage forms (e.g., tablets and capsules) by detecting and characterizing surface anomalies such as cracks, chips, discolorations, and irregular shapes. This service is vital for maintaining product quality and compliance.

Why Choose STEMart?

Unmatched Expertise: Our team of scientists and technicians brings extensive experience in pharmaceutical testing, particularly for biologics and solid dosage forms, ensuring accurate and reliable outcomes.
Cutting-Edge Technology: We utilize the latest microscopy systems, such as Cryo-EM with direct electron detectors, MFI, and AI-integrated platforms, delivering superior imaging quality and precision.
Comprehensive Solutions: From sample preparation to detailed reporting, we offer end-to-end services tailored to your specific needs.
Regulatory Compliance: Our methods adhere to industry standards (e.g., USP, EP, FDA), providing the documentation required for regulatory success.
Customized Approach: We collaborate closely with you to address unique challenges, offering personalized solutions that drive value and efficiency.

By partnering with STEMart, you gain a trusted ally dedicated to advancing your pharmaceutical development and quality assurance goals. Contact us today to learn more about how our Optical and Microscopy Imaging Analysis services can support your needs.