Biopharmaceuticals are complex molecules that often require conditions to remain stable and intact. Throughout development these molecules are stressed to determine those stable conditions and to identify degradation products that may form during manufacturing or if the drug is improperly stored.
Monoclonal antibodies (mAbs) currently represent the largest class of therapeutic drugs made by the biotechnology industry and will play a significant role in the future of pharmacological disease interventions. Purification, characterization, and monitoring of mAbs are critically important to drug development, with a variety of analysis techniques routinely used. Due to the heterogeneity in hydrophobic structure of mAbs, reversed-phase separation is becoming an option for monitoring purity and stability during manufacturing, formulation and storage.
Shimadzu offers reliable solutions for identifying and quantifying degradation products, and monitoring them throughout production and formulation, using liquid chromatography systems, triple quadruple mass spectrometers for quantitation, and high-resolution MALDI-TOF/TOF mass spectrometers.