Analytical Method Development

Capsugel provides full analytical development and validation in support of formulations for clinical-trial materials and commercial products. We have analytical staff located at each of our integrated product-development sites. From our analytical development laboratories, which are fully Good Laboratory Practice (GLP)-compliant, our experienced teams of analysts provide:

EARLY DEVELOPMENT SERVICES

LATE-STAGE DEVELOPMENT SERVICES

Compound handling protocol

Manufacturing process development

Drug characterization

Quality Control (QC) method development

Excipient compatibility testing and selection

Analytical method optimization, qualification and validation

Pre-formulation and formulation development

Cleaning methods/ verification

Analytical method development and qualification 

Product release and stability testing

Release and stability testing 

Clinical trial material manufacture

Clinical trial material manufacturing

QC/ QP Release 

Investigational New Drug (IND) / Investigational Medical Product Dossier (IMPD) support

Regulatory dossier support

Capsugel’s unique combination of high quality science and engineering expertise is core to our offering at each stage of a product’s development and manufacturing cycle. We have formulated and advanced over 4,000 compounds across a myriad of problem statements, and Capsugel’s product-development sites have more than 70 years of collective experience producing clinical-trial materials. 

Over the years, we have developed proprietary technology-selection methodologies, predictive models, expert systems, formulation reference tools, specialized lab-scale equipment and microtesting methods, which help ensure rapid feasibility assessments as well as optimized product design and development.