post published at THERMO AnalyteGuru™ Blog by Lori Stansberry
Analytical strategy is key for creating and generating data showing comparability of a biosimilar. This analytical strategy can provide important clinical similarity data streamlining and speeding up the development process. Fully understanding the effects of the manufacturing process on the product at early stages of development allows for generation of suitable methods for product monitoring in later stages. Currently developing a biosimilar is a multi-year process generating considerable development costs, with each biosimilar costing $150-$200 million to develop. Early process understanding can help better define risks and allow for better risk management strategies. For the success of biosimilars, it is important for this process to quickly identify successes and where changes are needed in the process.
Identifying analytical methodologies providing characterization and comparability data in a shorter time can reduce the overall product development and development costs. High-resolution accurate mass (HRAM) mass spectrometry techniques can bring fast answers during biosimilar development and allow for stringent process control throughout development and into manufacturing. Learn more in this recent application note using mass spectrometry to quickly compare biosimilars to reference products on an intact protein level.
Read the full post here.