Vivek Farkade

Biography

More than 13 years experience in downstream process development and characterization for Bio-pharmaceuticals Process understanding and Risk assessment using Failure mode effect analysis (FMEA) Ability to scale up/scale down the processes with comparability and equivalency exercise Through knowledge of EMEA requirements for Module 3 Statistical analysis of process characterization data to identify the design space for the unit operation performance. Statistical analysis using JMP. Development and execution of impurity clearance studies to under the process capability Isolation of impurities for characterization and analytical method development Product quality improvement through continuous process improvement Specialties:Process characterization, Statistical analysis for identification of design space, Risk assessment (FMEA), scale down model development, scale up, process performance qualification (process validation), process development, Project Management

Research Interest

bioprocess technology