Particle Characterization & Testing

GMP-compliant particle characterization to support pharmaceutical development and quality control

Kymos Group provides GMP-compliant particle characterization and testing services to support the development, manufacturing, and quality control of pharmaceutical products. Particle attributes such as size, morphology, and surface properties play a critical role in product performance, stability, and manufacturability, particularly in complex formulations and advanced drug delivery systems.

Our integrated analytical approach combines complementary techniques to generate a comprehensive understanding of particle and solid-state properties. This enables informed decision-making throughout the product lifecycle: from early development to batch release and post-approval changes.

Services

Our catalog of services include:

Particle Size & Morphology

  • Identification of polymorphism, crystallinity, and amorphous content using X-ray powder diffraction (XRPD)
  • Assessment of solid-form transformations under stress and stability conditions
  • Thermal and spectroscopic analysis using DSC/TGA, Raman and FTIR

  • Measurement of surface area and porosity using gas adsorption techniques (BET)
  • Evaluation of particle interactions and aggregation behavior

  • Development and validation of particle-related analytical methods under GMP
  • Routine testing for quality control and batch release

Services

Key Applications

Particle characterization and testing play a critical role across the pharmaceutical lifecycle, providing the data needed to understand product performance, ensure quality, and support decision-making in complex development and manufacturing scenarios.

  • Formulation and process development

  • Stability and stress studies (solid-form and particle transformations)

  • Quality control and batch release testing

  • Investigation of variability and out-of-specification results (OOS/OOT)

  • Comparability studies following formulation or process changes

OUR EXPERIENCE

We can help you with:

Our experience covers a wide range of pharmaceutical products and materials, including:

  • APIs (small molecules) and excipients
  • Drug products (solid, semi-solid, and liquid forms, including injectables)

  • Biologics and complex formulations

  • TIDES (oligonucleotides and peptides)

Team Discussion

Why Choose KYMOS?

  • GMP Expertise:

    • GMP-certified laboratories supporting particle characterization and testing across development and commercial stages.

  • Regulatory Experience:

    • Experience supporting regulatory submissions and responding to analytical challenges in highly regulated environments.

  • Integrated Analytical Approach:

    • Combination of complementary techniques to provide a comprehensive understanding of particle and solid-state properties.

  • Proven Track Record

    • More than 20 years of experience supporting pharmaceutical companies across a wide range of products and modalities.

Services

All Solid-State Characterization Services

Oligo testing

Bioanalysis of Nucleic Acids

Quantification of nucleic acids as therapeutics, biomarkers or similar with standardized and reproducible methods according to GLP.

Pharmakokinetic Evaluation

Pharmacokinetic Evaluation & Statistics

Pharmacokinetic calculations and statistics of bioanalytical data from preclinical and clinical studies with Phoenix WinNonlin®.

Percutaneous Absorption

Percutaneous Absorption

Percutaneous absorption assays for topical semisolid drug products: In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT)

LC-MSMS Sciex API 5500 QTrap

Bioequivalence Studies

Bioanalysis for bioequivalence studies of generics in collaboration with the sponsor and/or the selected clinical phase centre.

 
 

Contacto

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