BIOSIMILAR COMPARABILITY STUDIES
Kymos is a GMP-certified an EMA and FDA inspected CRO offering full biosimilar comparability studies. Releasing biosimilar drugs to the market is extremely challenging. It calls for well-equipped laboratories able to conduct all assays, ensuring purity, identity and potency. Labs providing biosimilar comparability studies need to have GMP certifications and manufacturing authorizations, subject to periodic inspections by regulatory bodies such as the FDA and the EMA. Kymos has all this. We follow a step-by-step comparability model for biosimilar drugs focused on critical quality attributes (CQAs), identified and classified according to their risk ranking. The number and nature of required assays is determined from the list below on a case-by-case basis:
| GENERAL ANALYTICAL TECHNIQUES FOR BIOSIMILARS | STRUCTURAL ANALYSIS OF THE BIOSIMILAR |
|---|---|
A preliminary overview of the quality attributes of the biosimilar molecule during initial development phases:
| Full molecular identification of the biosimilar for strain selection, bioprocess and final product characterization:
|
CONFORMATIONAL ANALYSIS OF THE BIOSIMILAR | IDENTITY, CONTENT, PROTEIN IMPURITIES |
Protein folding and 3D conformation determine biological activity and immunogenicity of the biosimilar:
| Chromatographic patterns are quality indicators of the purification process:
|
PROCESS-RELATED IMPURITIES | BIOLOGICAL ACTIVITY OF THE BIOSIMILAR |
Other quality indicators of the purification process and also linked to safety concerns:
| Biological tests to confirm molecule activity of the biosimilar:
|
