Let Maurice Help You Get Your Biosimilars to Market
Biopharmaceuticals represent one of the fastest growing segments of the drug market, with over 100 billion dollars in annual sales. The development of biosimilars – biotherapeutic products similar to previously licensed reference biotherapeutic products in terms of quality, safety and efficacy– therefore represents a prime opportunity as the innovator biologics go off patent.
In order for a biosimilar to be approved for market, regulatory agencies require that certain critical quality attributes (CQA) must be met to show the comparability of the biosimilar to the innovator drug. One CQA concerns charge or size heterogeneity which is often analyzed using imaged capillary isoelectric focusing (icIEF) or capillary electrophoresis sodium dodecyl sulfate (CE-SDS).
Maurice, our next-gen capillary electrophoresis system, combines both icIEF and CE-SDS detection schemes in a single, automated platform, to provide sensitive, rapid, accurate, and reproducible data for profiling biosimilars and generating comparison data to innovators. Compared to other systems, Maurice enables platform methods which can be applied to a variety of protein molecules. With Maurice, you can accelerate your biosimilars development, and get safe therapeutics to market, faster.
See our protocol, Biosimilar Platform Methods on Maurice, to learn how Maurice can be used for biosimilar characterization.
Then see our protocols on how Maurice is used to compare icIEF data for 7 different innovator and biosimilar molecules currently on the market.
