Analysis of Biosimilars, Follow-on Biologics

Solvias has a track record over several years in supporting the cGMP analysis of biosimilars (European terminology) or follow-on biologics/follow-on protein products (terminology of the US Food and Drug Administration).

The same analytical tasks are required to analyze an innovator product, but with one important addition. Whilst the regulatory systems differ around the world there is one common feature: the need for extensive and in-depth analytical comparability between the innovator product and the biosimilar (follow-on biologic). In view of the notorious risk aversion of regulators, it is advisable not to attempt to take short cuts with the scientific quality and cGMP compliance standards.

Analysis of Biosimilars, Follow-on Biologics and the key aspects to support comparability studies:

  • excellent scientific problem solvers
  • extensive range of physical chemical methods for addressing key issues: aggregation, glycosylation and stability-indicating assays
  • robust cGMP quality system
  • experience

 

Heterogeneity of glycosylation is one of the most problematic issues; this arises from the biochemical complexity of the cellular production systems used. Solvias has a vast array of well established technologies, from standard industry methods right up to CE –MS and MALDI ToF-ToF for challenging cases. The Solvias advantage is that all parameters may be checked for accuracy using an alternative method, and the best method for your particular needs can be selected.