A biosimilar is an almost identical version of an originator product. To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be demonstrated. Biomolecules, however, exhibit high structural complexity and are often sensitive to alterations in the manufacturing process.
This work aims to demonstrate different strategies to alter the distribution of charge variants of a monoclonal antibody (mAb) in a downstream polishing step.
Read more in this application note.