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Biopharmaceutical Drug Developers topic: Detection of protein aggregation by AF4/MALS
The formation of aggregates in biopharmaceuticals such as monoclonal antibodies (MAbs), represents a severe problem, which has also been addressed by FDA authorities recently. Particularly their potential to trigger or enhance undesirable immune responses may cause adverse clinical effects or compromise the drug’s safety and efficiency. Wyatt Technology has recently launched the 4th generation AF4/MALS technology, specifically aiming at providing drug developers a truly orthogonal method to SEC. The attached paper gives you more background and technical information on this method.
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