Protein analysis for comparability
Solvias has wealth of experience to support the CGMP analysis of biosimilars, also known as follow-on biologics. Global regulations share in common the need for extensive and in-depth analytical comparability between the innovator product and the biosimilar / follow-on biologic. Maintaining the highest standards in terms of scientific quality and CGMP compliance at this stage of development is therefore essential.
Using our highly experienced scientific staff and sophisticated methodologies, we support your comparability studies according to ICH guideline Q5E with:
- an extensive range of physical chemical methods for addressing key issues:
aggregation, truncation, glycosylation, primary, secondary and tertiary structure related changes and stability-indicating assays
- a robust CGMP quality system
Solvias is well equipped to deal with challenges such as heterogeneity of glycosylation, using LC-MS and MALDI TOF as well as standard industry methods. We have the scale and flexibility to verify parameters using alternative methods if required and to exactly match the needs of your comparability studies.