Q.1 The application of Liquid Chromatography-Mass Spectroscopy (LC-MS) has become significant in the quality control of therapeutics and pharmaceutical formulations. Discuss this in terms of contemporary drug analysis and bulk pharmaceuticals.

Q.2 Antibody fragments are generating increased interest as the demand for target therapeutics with improved efficacy continues to grow. These molecules present unique challenges for the “traditional” processes used for the development and manufacture of monoclonal antibodies. Discuss.

Q.3 Evaluation of the immunogenicity of a new drug is a multidisciplinary systematic assessment. Critically evaluate the current guidelines for the immunogenicity assessment of biotechnology-derived therapeutic proteins.