Accurate Solutions For Identifying Modifications And Degradation Products
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) 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 charge and hydrophobic structure of mAbs, ion exchange and reversed-phase separation is becoming an option for monitoring purity and stability during manufacturing, formulation and storage.
Agilent has reliable solutions for identifying degradation products, and monitoring them throughout production and formulation, using Liquid Chromatography systems a wide variety of column chemistries, and electrophoresis.