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

Solid-State Characterization

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

Surface Area & Particle Interactions

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

Method Development & GMP Testing

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

Where can we help

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)

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