A Biosimilar Workflow: From Purification To Characterization

Biologics are medicines produced using living cells and highly complex manufacturing processes. As the number of biologics with expired patents increases, biosimilar medicines promise to be an attractive, cost-effective alternative. To bring a biosimilar to market, developers are required to demonstrate high similarity to the approved biological originator product, which includes evidence that demonstrates no clinically meaningful differences between the biosimilar and the reference biologic. This is provided as part of the totality of evidence reported to regulatory agencies.

Learn More about the Biosimilar Workflow Here

We present a workflow that guides you through four of the main steps of biosimilar development: purification, impurity analysis, comparability studies, and bioanalysis. We designed a three-step, cost-effective purification strategy that includes impurity analysis for adalimumab, a HUMIRA-like biosimilar. A downstream cell-based assay was designed to assess comparability and efficacy of the biosimilar. We also developed a series of immunoassays to measure other characteristics such as immunogenicity and pharmacokinetics (PK), which are important considerations for the development of any biologic or biosimilar.