Let ProteinSimple 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.
ProteinSimple's analytical instruments are automated, high-throughput systems that can get you the high-quality, reproducible critical quality attribute (CQA) data you need to show the comparability of biosimilars to their innovator drugs for regulatory approval. Our next-generation systems are easy to use and will save you precious time and money. Accelerate your biosimilars development, and get safe therapeutics to market, faster.
Get Charge Heterogeneity And Size Data With Maurice
Maurice, our next-gen capillary electrophoresis system, combines both imaged capillary isoelectric focusing (icIEF) and capillary electrophoresis sodium dodecyl sulfate (CE-SDS) detection schemes in a single, automated platform. Get method development in hours, not weeks, with Maurice. He also enables platform methods which can be applied to a variety of protein molecules.
See our protocol, Biosimilar Platform Methods on Maurice, to learn how Maurice can be used for biosimilar characterization.
Also see our protocols on how Maurice is used to compare icIEF data for 7 different innovator and biosimilar molecules currently on the market.
Evaluate Biosimilar Stability With MFI
Micro-Flow Imaging (MFI) directly images subvisible particles in solution. With its ability to capture data on 10 different morphological parameters and its powerful analysis software, MFI can detect and differentiate between particle subpopulations, including translucent protein aggregates, which can often be missed by other particle detection methods.
The formation of protein aggregates can be an important indicator of biosimilar stability. MFI provides sensitive and reproducible detection of these aggregates and other particle contaminants, giving you valuable and early indicators of stability during formulation, development, and manufacturing.
Read our application note, Evaluating The Stability Of Therapeutic Biosimilar Monoclonal Antibodies With Micro-Flow Imaging, to see how MFI can be used to evaluate biosimilar and therapeutic protein stability.
