Biotherapeutic QC: Time to Meet MAM
How high-resolution mass spectrometry and the multiple attribute method could give a boost to biopharma analytics, particularly with continuous processing on the horizon.
Simon Cubbon |
The well-known clinical benefits of biologics come at a price: large molecule drugs are highly complex, leading to analytical challenges throughout the development pipeline – from discovery, through to bioprocessing, quality control and release. Monoclonal antibodies (mAbs) and other complex drug products, such as antibody-drug conjugates (ADCs), must be exhaustively characterized to ensure the safety and efficacy of a batch before release. Even the smallest change or post-translational modification, such as oxidation, deamidation, or glycosylation, has the potential to render the drug batch ineffective, or worse, create negative off-target effects for the patient.
Process development also faces challenges that are unique to the bioproduction environment, which, when combined with technological limitations of selectivity, fluidics and sterility can create an arduous sample analysis process, if the correct methodologies are not carefully chosen.
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