Physical Parameter Testing

At STEMart, our Physical Parameter Testing services represent a cornerstone of our analytical testing capabilities within pharmaceutical services. This advanced suite of tests is designed to evaluate the fundamental physical properties of drug substances and biologics, providing critical data that underpins formulation development, stability assessment, and regulatory compliance. Our Physical Parameter Testing encompasses a broad range of physicochemical and structural analyses tailored to meet the needs of small molecules, therapeutic proteins, monoclonal antibodies (mAbs), and complex biologics.

Our state-of-the-art analytical platforms deliver precise, reproducible, and actionable insights into the behavior of pharmaceutical materials under varying conditions. From aggregation tendencies to thermodynamic stability, solubility profiles, and microscopic structural integrity, we offer a holistic approach to characterizing your drug candidates. By integrating cutting-edge technology with deep scientific expertise, STEMart ensures that your products meet the rigorous standards of safety, efficacy, and quality demanded by the biopharmaceutical industry.

Illustration of medicines (AI generated)

Our Services

Aggregation Behavior Analysis

Our Aggregation Behavior Analysis service provides a detailed investigation into the aggregation tendencies of therapeutic proteins, monoclonal antibodies, fusion proteins, and other biologics. Aggregation is a critical quality attribute that can affect drug stability, efficacy, and immunogenicity. Using advanced analytical techniques, we quantify key parameters such as Critical Micelle Concentration (CMC), aggregation kinetics, protein aggregation onset temperature (Tagg), and dose-dependent aggregation behavior. These insights are vital for optimizing formulations, ensuring long-term stability, and minimizing risks during manufacturing and storage. With STEMart, you gain access to precise, reproducible data that supports regulatory compliance and enhances product quality.

Thermodynamic and Kinetic Properties Evaluation

Our Thermodynamic and Kinetic Properties Evaluation service offers an in-depth characterization of the stability, binding interactions, and structural dynamics of biomolecules. This suite of analyses includes protein melting temperature (Tm) determination, ligand binding affinity assessments, binding kinetics, and folding/unfolding kinetics studies. Leveraging cutting-edge technologies such as Surface Plasmon Resonance (SPR), Bio-Layer Interferometry (BLI), and Microscale Thermophoresis (MST), we provide high-resolution data on the energy landscapes and time-dependent behaviors of your drug candidates. This service is essential for rational drug design, ensuring optimal target engagement, and validating stability under physiological or stress conditions.

Solubility and Solution Behavior Analysis

Our Solubility and Solution Behavior Analysis service evaluates how drug substances interact with solvents across a range of environmental conditions. This comprehensive testing suite assesses maximum solubility, pH-dependent solubility, ionic strength effects, and solution turbidity—key factors influencing bioavailability and formulation success. Designed to address challenges such as poor solubility or phase separation, our analyses support the development of robust liquid formulations and enhance drug performance. With high-throughput screening capabilities and validated methodologies, STEMart delivers actionable insights to optimize solubility profiles and ensure product consistency from preclinical stages to market entry.

Optical and Microscopy Imaging Analysis

Our Optical and Microscopy Imaging Analysis service leverages advanced imaging technologies to visualize and characterize the physical and structural properties of pharmaceutical materials at the microscopic level. From particle morphology assessments to protein structural visualization and surface defect identification, our portfolio includes techniques such as Cryo-Electron Microscopy (Cryo-EM), Micro-Flow Imaging (MFI), and AI-integrated microscopy. This service is critical for detecting impurities, ensuring product uniformity, and supporting quality assurance in biologics and solid dosage forms. By providing detailed imaging and comprehensive reporting, we help clients meet stringent regulatory standards and drive innovation in product development.

At STEMart, we are committed to transforming your biopharmaceutical development with precision, innovation, and reliability. Contact us today to learn how our Physical Parameter Testing services can elevate your project and ensure the success of your pharmaceutical products.