5^th European Biosimilars Congress

Biography

Biography: Alexander Pitters

Abstract

Mammalian cell cultures are complex processes where cells are cultivated under highly controlled conditions using media with a very high number of components. Current effort is focused on obtaining a better understanding of mammalian cell cultures by cultivating predominantly CHO cells for therapeutic protein production. To ensure a healthy progression of the cell culture, it is important to understand and monitor the stages of the biologic manufacturing. In order to build quality into a process a primary step is to analyze the process, understand what the critical quality attributes are, and monitor or rather control those factors. Consequently, there is a significant interest and value in techniques that provide instantaneous response for monitoring and analyzing biopharmaceutical processes. Molecular techniques - such as Raman spectroscopy - are widely used for PAT applications, because they provide in-situ information in real-time. Kaiser Raman spectroscopy is a method by which multiple bioprocess assays can be measured in situ within the bioreactor or fermenter environment. Raman is a fundamental vibrational spectroscopic technique that provides chemical and physical information that can be used to generate multi-component qualitative and quantitative predictive models. The presence of water does not interfere with the spectrum as it does with other spectroscopic methods such as NIR and mid-IR. Thus, Raman is well-suited for a host of upstream and downstream bioprocess applications. Real-time measurements within Biopharma are achieved for Glucose, Glutamine, Glutamate, Lactate, Ammonium, Viable Cell Density, Total Cell Density, Osmolality, Monoclonal Antibodies and Viability. The analyzer software enables a fully integrated bioprocess management and the instruments allow to control 4 bioreactors from a working distance of 1 to 1000 m. In recent years, Kaiser Raman has opened up new avenues to bioprocess analytics by demonstrating a technology that is robust, scaleable, provides in situ knowledge, and is transferable between cell lines, media feedstocks, and process conditions. During process development, Raman is now crucial for adopting QbD principles to define manufacturing design spaces and demonstrate holistic process and quality understanding. During production, a single Raman sensor can be used to monitor and enable control of several critical parameters in real time. Compared to traditional off-line analytical methods, in situ Raman reduces cost, consumables, sterility risk, equipment maintenance, and operator overburden. The wealth of bioprocess information enabled by in situ, real-time Raman is being realized by many companies to deploy leaner, continuous, and hybrid biopharmaceutical manufacturing. Analyzers can be used to study solids, liquids or gas without sampling accessories or preparation. Kaiser Optical Systems is the leader in Raman instrumentation and advanced holographic components for spectroscopy. Products and services are positioned in pharmaceutical and chemical manufacturing around the world.