Multivariate Analysis for Process Understanding, Monitoring, Control, and Optimization of Lyophilization Processes

The biopharmaceutical industry has entered a new era. Attention is now being paid to real-time process monitoring, real-time process control, continuous improvement of processes, and quick product technology transfer. Terms like Quality by Design (QbD), design space, control strategy, process analytical technology, process signature are now used to reflect the current state. Multivariate statistical analysis has played an integral part in several industries, enabling process understanding, utilization of real-time analyzers, and real-time product release. It is therefore appropriate to see it as an integral part of the biopharmaceutical industry effort to address issues like design space, control strategy, real-time process signature monitoring, process understanding, and correct technology transfer. This chapter discusses the fundamentals behind multivariate methods for such purposes.