Unveiling critical parameters: optimizing biosimilar antibody production

Introduction:The production of biosimilar antibodies involves optimizing several process parameters to maximize yield.Statistical methods, particularly Design of Experiments (DoE), are essential for identifying and defining critical parameters.This study aimed to evaluate and determine the key parameters in the biosimilar antibody production process using a DoE approach, with a focus on the impact of temperature, pH, impeller speed, and dissolved oxygen (DO) levels.Objectives: This study aimed to define the critical process parameters (temperature, pH, impeller speed, and DO influencing biosimilar antibody production and to estimate their operational ranges based on their impact on antibody productivity.Methodology: A review of recent literature (last five years) was conducted to identify relevant parameters and their typical operational ranges in biosimilar antibody production.Based on this, a multifactorial experimental design was created to assess four key parameters: impeller speed, process temperature, pH, and DO.The experiment was conducted in 100 mL mini-bioreactors, and antibody productivity was evaluated by ELISA and SDS-PAGE, serving as response variables to assess the influence of each parameter.Results: Among the four parameters studied, only temperature and pH showed statistical significance in relation to antibody productivity.These two variables were found to be critical in the process, with a clear impact on antibody yield.Impeller speed and DO did not exhibit significant effects within the evaluated ranges. Conclusion:The DoE methodology proved effective in identifying temperature and pH as critical parameters for biosimilar antibody production.These results provide valuable insights into the process and suggest that further research is needed to refine the operational ranges of these parameters.Further investigation is needed to optimize large-scale production.