Particle Characterization & Testing<\/h1><\/div>GMP-compliant particle characterization to support pharmaceutical development and quality control<\/p>\n<\/div>
Talk to an expert<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div>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.<\/p>\n
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.<\/p>\n<\/div><\/div><\/div>
![](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%272048%27%20height%3D%271536%27%20viewBox%3D%270%200%202048%201536%27%3E%3Crect%20width%3D%272048%27%20height%3D%271536%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\")
<\/div><\/div><\/div><\/div>![](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271920%27%20height%3D%27900%27%20viewBox%3D%270%200%201920%20900%27%3E%3Crect%20width%3D%271920%27%20height%3D%27900%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\")
<\/div><\/div>Services<\/p>\n<\/div>
<\/div><\/div>Our catalog of services include:<\/h2><\/div><\/i><\/i><\/span>Particle Size & Morphology<\/span><\/a><\/h3><\/div>\n\n- Determination of particle size distribution from nano to micron range using laser diffraction and dynamic light scattering (DLS)<\/span><\/li>\n
- Morphological assessment using optical microscopy and polarized light microscopy (PLM)<\/span><\/li>\n
- Evaluation of particle shape and heterogeneity<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Solid-State Characterization<\/span><\/a><\/h3><\/div>\n\n- Identification of polymorphism, crystallinity, and amorphous content using X-ray powder diffraction (XRPD)<\/li>\n
- Assessment of solid-form transformations under stress and stability conditions<\/li>\n
- Thermal and spectroscopic analysis using DSC\/TGA, Raman and FTIR<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Surface Area & Particle Interactions<\/span><\/a><\/h3><\/div>\n\n- Measurement of surface area and porosity using gas adsorption techniques (BET)<\/li>\n
- Evaluation of particle interactions and aggregation behavior<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Method Development & GMP Testing<\/span><\/a><\/h3><\/div>\n\n- Development and validation of particle-related analytical methods under GMP<\/li>\n
- Routine testing for quality control and batch release<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Services<\/p>\n<\/div>
<\/div><\/div>Key Applications<\/h2><\/div>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.<\/p>\n<\/div>
- <\/i><\/span>\n
Formulation and process development<\/p>\n<\/div><\/li>
- <\/i><\/span>Stability and stress studies (solid-form and particle transformations)<\/div><\/li>
- <\/i><\/span>\n
Quality control and batch release testing<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Investigation of variability and out-of-specification results (OOS\/OOT)<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Comparability studies following formulation or process changes<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
<\/div><\/div><\/div><\/div>OUR EXPERIENCE<\/p>\n<\/div>
<\/div><\/div>We can help you with:<\/h2><\/div>Our experience covers a wide range of pharmaceutical products and materials, including:<\/p>\n<\/div>
- <\/i><\/span>APIs (small molecules) and excipients<\/div><\/li>
- <\/i><\/span>Drug products (solid, semi-solid, and liquid forms, including injectables)<\/div><\/li>
- <\/i><\/span>\n
Biologics and complex formulations<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
TIDES (oligonucleotides and peptides)<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
<\/i><\/span><\/div><\/i><\/span><\/div><\/i><\/span><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>![\"Team](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27988%27%20height%3D%27988%27%20viewBox%3D%270%200%20988%20988%27%3E%3Crect%20width%3D%27988%27%20height%3D%27988%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" "\\"Team")
<\/span><\/div><\/div><\/div>Why Choose KYMOS?<\/h2><\/div>- <\/i><\/span>\n
GMP Expertise:<\/strong><\/h3>\n\n- GMP-certified laboratories supporting particle characterization and testing across development and commercial stages.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Regulatory Experience:<\/strong><\/h3>\n\n- Experience supporting regulatory submissions and responding to analytical challenges in highly regulated environments.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Integrated Analytical Approach:<\/strong><\/h3>\n\n- Combination of complementary techniques to provide a comprehensive understanding of particle and solid-state properties.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Proven Track Record<\/h3>\n\n- More than 20 years of experience supporting pharmaceutical companies across a wide range of products and modalities.<\/li>\n<\/ul>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div><\/span><\/span><\/span>
Services<\/p>\n<\/div>
<\/div><\/div>All Solid-State Characterization Services<\/h2><\/div><\/div><\/div><\/span><\/a><\/span>![\"Oligo](\"https:\/\/kymos.com\/wp-content\/uploads\/2021\/09\/PROLYTIC_OLIGO_qPCR_Prolytic21-238.jpg\" "\\"PROLYTIC_OLIGO_qPCR_Prolytic21-238\\"")
<\/span><\/div>Bioanalysis of Nucleic Acids<\/h3><\/h4><\/div>Quantification of nucleic acids as therapeutics, biomarkers or similar with standardized and reproducible methods according to GLP.<\/p>\n<\/div><\/div><\/div>
GMP-compliant particle characterization to support pharmaceutical development and quality control<\/p>\n<\/div>
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.<\/p>\n
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.<\/p>\n<\/div><\/div><\/div>
Services<\/p>\n<\/div>
Our catalog of services include:<\/h2><\/div><\/i><\/i><\/span>Particle Size & Morphology<\/span><\/a><\/h3><\/div>\n\n- Determination of particle size distribution from nano to micron range using laser diffraction and dynamic light scattering (DLS)<\/span><\/li>\n
- Morphological assessment using optical microscopy and polarized light microscopy (PLM)<\/span><\/li>\n
- Evaluation of particle shape and heterogeneity<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Solid-State Characterization<\/span><\/a><\/h3><\/div>\n\n- Identification of polymorphism, crystallinity, and amorphous content using X-ray powder diffraction (XRPD)<\/li>\n
- Assessment of solid-form transformations under stress and stability conditions<\/li>\n
- Thermal and spectroscopic analysis using DSC\/TGA, Raman and FTIR<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Surface Area & Particle Interactions<\/span><\/a><\/h3><\/div>\n\n- Measurement of surface area and porosity using gas adsorption techniques (BET)<\/li>\n
- Evaluation of particle interactions and aggregation behavior<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Method Development & GMP Testing<\/span><\/a><\/h3><\/div>\n\n- Development and validation of particle-related analytical methods under GMP<\/li>\n
- Routine testing for quality control and batch release<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Services<\/p>\n<\/div>
<\/div><\/div>Key Applications<\/h2><\/div>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.<\/p>\n<\/div>
- <\/i><\/span>\n
Formulation and process development<\/p>\n<\/div><\/li>
- <\/i><\/span>Stability and stress studies (solid-form and particle transformations)<\/div><\/li>
- <\/i><\/span>\n
Quality control and batch release testing<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Investigation of variability and out-of-specification results (OOS\/OOT)<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Comparability studies following formulation or process changes<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
<\/div><\/div><\/div><\/div>OUR EXPERIENCE<\/p>\n<\/div>
<\/div><\/div>We can help you with:<\/h2><\/div>Our experience covers a wide range of pharmaceutical products and materials, including:<\/p>\n<\/div>
- <\/i><\/span>APIs (small molecules) and excipients<\/div><\/li>
- <\/i><\/span>Drug products (solid, semi-solid, and liquid forms, including injectables)<\/div><\/li>
- <\/i><\/span>\n
Biologics and complex formulations<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
TIDES (oligonucleotides and peptides)<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
<\/i><\/span><\/div><\/i><\/span><\/div><\/i><\/span><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/span><\/div><\/div><\/div>Why Choose KYMOS?<\/h2><\/div>- <\/i><\/span>\n
GMP Expertise:<\/strong><\/h3>\n\n- GMP-certified laboratories supporting particle characterization and testing across development and commercial stages.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Regulatory Experience:<\/strong><\/h3>\n\n- Experience supporting regulatory submissions and responding to analytical challenges in highly regulated environments.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Integrated Analytical Approach:<\/strong><\/h3>\n\n- Combination of complementary techniques to provide a comprehensive understanding of particle and solid-state properties.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Proven Track Record<\/h3>\n\n- More than 20 years of experience supporting pharmaceutical companies across a wide range of products and modalities.<\/li>\n<\/ul>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div><\/span><\/span><\/span>
Services<\/p>\n<\/div>
<\/div><\/div>All Solid-State Characterization Services<\/h2><\/div><\/div><\/div><\/span><\/a><\/span><\/span><\/div>Bioanalysis of Nucleic Acids<\/h3><\/h4><\/div>Quantification of nucleic acids as therapeutics, biomarkers or similar with standardized and reproducible methods according to GLP.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Particle Size & Morphology<\/span><\/a><\/h3><\/div>\n\n- Determination of particle size distribution from nano to micron range using laser diffraction and dynamic light scattering (DLS)<\/span><\/li>\n
- Morphological assessment using optical microscopy and polarized light microscopy (PLM)<\/span><\/li>\n
- Evaluation of particle shape and heterogeneity<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Solid-State Characterization<\/span><\/a><\/h3><\/div>\n\n- Identification of polymorphism, crystallinity, and amorphous content using X-ray powder diffraction (XRPD)<\/li>\n
- Assessment of solid-form transformations under stress and stability conditions<\/li>\n
- Thermal and spectroscopic analysis using DSC\/TGA, Raman and FTIR<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Surface Area & Particle Interactions<\/span><\/a><\/h3><\/div>\n\n- Measurement of surface area and porosity using gas adsorption techniques (BET)<\/li>\n
- Evaluation of particle interactions and aggregation behavior<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Method Development & GMP Testing<\/span><\/a><\/h3><\/div>\n\n- Development and validation of particle-related analytical methods under GMP<\/li>\n
- Routine testing for quality control and batch release<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Services<\/p>\n<\/div>
<\/div><\/div>Key Applications<\/h2><\/div>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.<\/p>\n<\/div>
- <\/i><\/span>\n
Formulation and process development<\/p>\n<\/div><\/li>
- <\/i><\/span>Stability and stress studies (solid-form and particle transformations)<\/div><\/li>
- <\/i><\/span>\n
Quality control and batch release testing<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Investigation of variability and out-of-specification results (OOS\/OOT)<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Comparability studies following formulation or process changes<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
<\/div><\/div><\/div><\/div>OUR EXPERIENCE<\/p>\n<\/div>
<\/div><\/div>We can help you with:<\/h2><\/div>Our experience covers a wide range of pharmaceutical products and materials, including:<\/p>\n<\/div>
- <\/i><\/span>APIs (small molecules) and excipients<\/div><\/li>
- <\/i><\/span>Drug products (solid, semi-solid, and liquid forms, including injectables)<\/div><\/li>
- <\/i><\/span>\n
Biologics and complex formulations<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
TIDES (oligonucleotides and peptides)<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
<\/i><\/span><\/div><\/i><\/span><\/div><\/i><\/span><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/span><\/div><\/div><\/div>Why Choose KYMOS?<\/h2><\/div>- <\/i><\/span>\n
GMP Expertise:<\/strong><\/h3>\n\n- GMP-certified laboratories supporting particle characterization and testing across development and commercial stages.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Regulatory Experience:<\/strong><\/h3>\n\n- Experience supporting regulatory submissions and responding to analytical challenges in highly regulated environments.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Integrated Analytical Approach:<\/strong><\/h3>\n\n- Combination of complementary techniques to provide a comprehensive understanding of particle and solid-state properties.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Proven Track Record<\/h3>\n\n- More than 20 years of experience supporting pharmaceutical companies across a wide range of products and modalities.<\/li>\n<\/ul>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div><\/span><\/span><\/span>
Services<\/p>\n<\/div>
<\/div><\/div>All Solid-State Characterization Services<\/h2><\/div><\/div><\/div><\/span><\/a><\/span><\/span><\/div>Bioanalysis of Nucleic Acids<\/h3><\/h4><\/div>Quantification of nucleic acids as therapeutics, biomarkers or similar with standardized and reproducible methods according to GLP.<\/p>\n<\/div><\/div><\/div>
- \n
- Determination of particle size distribution from nano to micron range using laser diffraction and dynamic light scattering (DLS)<\/span><\/li>\n
- Morphological assessment using optical microscopy and polarized light microscopy (PLM)<\/span><\/li>\n
- Evaluation of particle shape and heterogeneity<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Solid-State Characterization<\/span><\/a><\/h3><\/div>
\n- \n
- Identification of polymorphism, crystallinity, and amorphous content using X-ray powder diffraction (XRPD)<\/li>\n
- Assessment of solid-form transformations under stress and stability conditions<\/li>\n
- Thermal and spectroscopic analysis using DSC\/TGA, Raman and FTIR<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Surface Area & Particle Interactions<\/span><\/a><\/h3><\/div>
\n- \n
- Measurement of surface area and porosity using gas adsorption techniques (BET)<\/li>\n
- Evaluation of particle interactions and aggregation behavior<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Method Development & GMP Testing<\/span><\/a><\/h3><\/div>
\n- \n
- Development and validation of particle-related analytical methods under GMP<\/li>\n
- Routine testing for quality control and batch release<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Services<\/p>\n<\/div>
<\/div><\/div>Key Applications<\/h2><\/div>
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.<\/p>\n<\/div>
- <\/i><\/span>\n
Formulation and process development<\/p>\n<\/div><\/li>
- <\/i><\/span>
Stability and stress studies (solid-form and particle transformations)<\/div><\/li>- <\/i><\/span>
\nQuality control and batch release testing<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nInvestigation of variability and out-of-specification results (OOS\/OOT)<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nComparability studies following formulation or process changes<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
OUR EXPERIENCE<\/p>\n<\/div>
<\/div><\/div>We can help you with:<\/h2><\/div>
Our experience covers a wide range of pharmaceutical products and materials, including:<\/p>\n<\/div>
- <\/i><\/span>APIs (small molecules) and excipients<\/div><\/li>
- <\/i><\/span>
Drug products (solid, semi-solid, and liquid forms, including injectables)<\/div><\/li>- <\/i><\/span>
\nBiologics and complex formulations<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nTIDES (oligonucleotides and peptides)<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
<\/i><\/span><\/div><\/i><\/span><\/div><\/i><\/span><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Why Choose KYMOS?<\/h2><\/div>
- <\/i><\/span>\n
GMP Expertise:<\/strong><\/h3>\n
- \n
- GMP-certified laboratories supporting particle characterization and testing across development and commercial stages.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Regulatory Experience:<\/strong><\/h3>\n
- \n
- Experience supporting regulatory submissions and responding to analytical challenges in highly regulated environments.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Integrated Analytical Approach:<\/strong><\/h3>\n
- \n
- Combination of complementary techniques to provide a comprehensive understanding of particle and solid-state properties.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Proven Track Record<\/h3>\n
- \n
- More than 20 years of experience supporting pharmaceutical companies across a wide range of products and modalities.<\/li>\n<\/ul>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div><\/span><\/span><\/span>
Services<\/p>\n<\/div>
<\/div><\/div>All Solid-State Characterization Services<\/h2><\/div><\/div><\/div>
<\/span><\/a><\/span><\/span><\/div>Bioanalysis of Nucleic Acids<\/h3><\/h4><\/div>
Quantification of nucleic acids as therapeutics, biomarkers or similar with standardized and reproducible methods according to GLP.<\/p>\n<\/div><\/div><\/div>
- More than 20 years of experience supporting pharmaceutical companies across a wide range of products and modalities.<\/li>\n<\/ul>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div>
- <\/i><\/span>
- <\/i><\/span>
- <\/i><\/span>
- Morphological assessment using optical microscopy and polarized light microscopy (PLM)<\/span><\/li>\n
![\"Team](\"https:\/\/kymos.com\/wp-content\/uploads\/2025\/02\/why-choose-kymos.png\" "\\"Team")
<\/span><\/div><\/div><\/div>![\"Pharmakokinetic](\"https:\/\/kymos.com\/wp-content\/uploads\/2021\/09\/PROLYTIC_OFFICE_Staff_Prolytic21-359.jpg\" "\\"PROLYTIC_OFFICE_Staff_Prolytic21-359\\"")
<\/span><\/div>![\"Percutaneous](\"https:\/\/kymos.com\/wp-content\/uploads\/2021\/09\/KYMOS-BIOAN_PER_ABS_Franz-cells-Phoenix-RDS-automatic-_20210623-BCN-0955.jpg\" "\\"KYMOS")
<\/span><\/div>