Characterization of Recombinant Therapeutic Monoclonal Antibodies and role of Compendial standards

Antibody-based therapy for cancer and immunological disorders has become established over the past 20 years and is now one of the most successful and important strategies for treating patients. The development of therapeutic antibodies requires a deep understanding of protein- engineering techniques, mechanisms of action, cancer serology, and resistance, and the interplay between the immune system and cancer cells. Monoclonal antibodies for human use are preparations of an immunoglobulin or a fragment of an immunoglobulin with specificity for a target ligand and produced from a single clone of cells.

Author(s): Ranjan Chakrabarti

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