bio therapeutic protein characterization with LC-MS insight to Biosimilars and comparability
Biotherapeutic proteins are changing the way patients are treated and the labs high end mass specs are used in. People with good knowledge within protein characterisation workflows are highly sought-after within the pharmaceutical industry.
Biotherapeutic protein characterisation benefits from the inherent ability of mass spectrometry to analyse the physicochemical properties of these complex compounds reproducibly and accurately.
These compunds go through extensive clinical trials, stability studies etc. All subsequent batches of biotherapeutics in production must be comparable to the biotherapeutic product that succeeded in clinical trials. The physicochemical testing of the product is an important strand of this work.
Biosimilars are biotherapeutic proteins produced by a different sponsor (company) than the originator compound. The requirements for proving physicochemical comparability between the originator and the biosimilar are very strict. Automated tools for the assessment of comparability are needed for batch-to-batch and innovator-biosimilar analysis to allow higher through-put and confidence in the data.
During this course we will go through what biotherapeutics are, what they do, and why the LC-MS characterisation is so important, and such a demanding task. We go through research and routine workflows that enable the products to be characterised correctly and accurately with high resolution mass spectrometry technique.