During the past few years, usage of multivariate methods in development and manufacturing processes has dramatically increased. Especially after the introduction of concepts like Process Analytical Technology (PAT) and Quality by Design (QbD), chemometrics is regarded as a central approach for increasing the efficiency of biotechnological processes and product development. In addition, it is a sophisticated tool for preventing or mitigating the risk of producing a poor quality product.
Design of Experiments (DoE) is considered best practice for knowledge building. Multivariate Data Analysis (MVDA) techniques are increasingly being used for scale- and batch-to-batch comparison investigations, and are making inroads into continuous real-time quality control and assurance.
Integrating and merging the capabilities of advanced chemometric methods into our scalable process control software BioPAT® MFCS/win enables both operators and management to look into systematic cost savings besides ensuring process reliability, safety and robustness.