Biopharmaceutics and Biologic Drugs

Biography

M.N Dixit is currently, the Test Facility Management and the Laboratory Director, Bioanalytical Laboratory Clinigene International Limited, Bangalore. Clinigene International limited is a Clinical Research Organization established in the year 2000 has added the Bioanalytical Laboratory for Large Molecules to its capability in the year 2011. Dixits’s previous experience includes a decade long career in the area of drug discovery before establishing the work of Bioanalytical laboratory for large molecules for immunogenicity and PK/TK assessment in the early part of 2006. He is personally responsible for establishing the various ligand binding assay formats under GLP and GCLP compliance such as ELISA, Chemiluminescence, Electro Chemiluminescence, Radio isotope, Cell based assays and Surface Plasmon Resonance based assay formats for the assessment of Immunogenicity and Pharmacokinetics and Toxicokinetics studies in both Non-Clinical and Clinical matrices. He was also one of the main scientists in developing sensitive Neutralizing antibody assays and antibody characterization for the regulatory submissions. He has immensely worked in developing sensitive ligand binding assays and validating these for use in study sample analysis. Several methods developed and validated from his laboratory were also transferred to laboratories in US/UK for speedy sample analysis there. He has 6 patents to his credit and also several publications in the journal of international repute. He has worked in most of the groups of biologics such as hormones, Cytokines, Growth factors and monoclonal antibodies for developing Immunogenicity and PK/TK assay formats acceptable to the regulatory agencies.

Research Interest

Pharmaceutics