Most biologics are large, complex molecules or mixtures of molecules. Our biopharmaceutical expertise can help you understand the composition of your drug product or substance. Characterization studies, method development, method validation, stability studies, quality control and batch release analysis under FDA Current Good Manufacturing Practice (CGMP) are at the heart of what Solvias offers. Our services are in accordance with the International Conference on Harmonisation (ICH) guidelines of technical requirements for registration of pharmaceuticals for human use.
We collaborate with you to plan milestone-based projects that fit your drug development program. Our proven expertise has been applied to complex analytical challenges such as monoclonal antibodies (mAbs), glycoproteins, PEGylated proteins and peptides and biosimilars (follow-on biologics).
Solvias has a solid reputation with market-leading biopharmaceutical companies for the characterization and QC analysis of monoclonal antibodies and other protein biologics. This means that businesses of all sizes, even smaller biotechs, can benefit from our knowledge of working with top level companies.