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Method Development for the Separation of Therapeutic Proteins (Biopolymers) – 2 Days
This course gives an extensive training on HPLC (UHPLC) method development for the separation of therapeutic proteins. The fundamentals of reversed-phase (RP), ion-exchange (IEX), hydrophobic interaction (HI) and size-exclusion (SE) chromatography are explained and discussed. Several examples on monoclonal antibodies (mAbs) and related products (such as antibody-drug conjugates /ADCs/) are presented.
MAbs and related therapeutics currently account for global sales of ≥USD 50 billion and are starting to receive competition from biosimilar incomes. Most pharmaceutical companies have entered the rapidly growing biosimilar market. Therefore, the appropriate and detailed analysis of biopharmaceuticals at different levels (top-down, middle-down and bottom-up) is demanded by the authorities.
Participants will learn the different two- and three-dimensional (3D) optimization models for all the above mentioned chromatographic modes. Fast and efficient method adjustment, transfer and robustness testing are also demonstrated.