Method Development for the Separation of Therapeutic Proteins (Biopolymers)
Dec 11 2017 - Dec 12 2017
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.
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Oct 23 2018 Frankfurt am Main, Germany
Oct 29 2018 Moscow, Russia
Oct 31 2018 Birmingham, UK
Oct 31 2018 Shanghai, China
Oct 31 2018 Tunis, Tunisia