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Expertise in antibody-drug conjugate (ADC) analytics from preclinical to commercial
The complex structure of ADCs, integrating both biological and chemical components, presents significant analytical testing and regulatory challenges. With a dedicated level 4 high-containment facility and a strong focus on safety, Solvias provides a full suite of analytical services to keep your development on track and within budget.
Broad-ranging capabilities
Solvias offers a comprehensive suite of cGMP-compliant ADC analytical services. Our unique combination of biological and physicochemical analyses, along with specialized CMC services, allows us to leverage our extensive expertise in the rapidly evolving field of ADC development.
Characterization and comparability
- Deep expertise to assess the physical, chemical, and performance properties of your ADC, with tailor-made packages to meet the specific needs of each molecule.
Impurities and by-products
- Complete range of impurity and contamination control services for ADCs, encompassing both chemical synthesis and biological production.
Drug substance & drug product release testing
- Routine cGMP release testing for ADCs utilizing a range of validated quality and stability-indicating methods, along with established compendial tests.
Stability studies
- Comprehensive stability testing portfolio with ready capacity and E&L capabilities covering all major dosage forms and complex delivery systems.
Biosafety testing
- Extensive biosafety testing portfolio with cGMP-compliant assays for detecting biological contaminants across diverse formulations.
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