Challenges In Biosimilar Monoclonal Antibody Cell Culture Process Development — Media Optimization Is A Key To Success

Biosimilar, a term synonymous to "follow-on biologic" requires very stringent and high standards of comparability with the original biologic drug that is being replicated.  Unlike conventional small molecules and chemical generics, "biogenerics" or biosimilars, especially monoclonal antibodies, have complex structure and function that are affected by slight changes in the manufacturing process.  Additionally, the rigor and stringent control standards imposed for biosimilars further increase the challenge and complexity for manufacturing process development of biosimilars.