Improving Cell Culture Process Control While Maintaining Quality of Biologics

When scaling-up a bioprocess, the goal is to improve productivity while maintaining quality attributes of cell products, such as monoclonal antibodies and recombinant proteins. However, traditional process control methods are often the rate-limiting steps in cell culture and are counter-productive to the aim of continuous processing of biologics.

This webinar will discuss methods for implementing real-time measurement of cell culture parameters to improve process control and achieve better productivity. The expert speaker will cover key upstream bioprocessing analytical requirements during suspension and adherent cell culture and explain how to meet those requirements using three key sensors.

The panelist will start with a background of the performance and expectations for analytical sensors during cell culture, including different bioreactor geometries and single-use bioreactors. He will also talk about the values of extracting and combining data from three essential sensors to develop process analytical technology (PAT) tools.

This will lead into a discussion on how PAT tools and the digitalization of analytical signals can feed advanced data-driven models to support pharma 4.0 initiatives. During this presentation, participants will learn how three sensors — a pH sensor, a dissolved oxygen sensor and a dissolved CO2 sensor — can make it possible to monitor and maintain the following six critical parameters from a process science perspective:

• pH of media with lowest pH drift post sterilization
• Tighter pH control with a dissolved CO2 (dCO2) control
• Oxygen measurement with no process-related signal noises affecting O2 control
• Oxidative stress
• Unwanted accumulation of dCO2
• Continuous calculation of O2/dCO2 molar ratio

Next, the speaker will tie the harmonization of these different parameters to different measurement points, including downstream operations, especially for pH/oxidation-reduction potential (ORP) and conductivity. The panelist will go into specific industry trends that relate to in-line, at-line and various off-line measurements. The speaker will then discuss the trend towards implementing CO2/ORP as a monitoring method possibly applied to process control strategies at both the smallest and largest manufacturing scale. He will conclude with a summary of how effective upstream analytics and their combination can help to improve ex vivo cell culture environment and bioprocess control.

Join this webinar to learn how real-time measurement of six critical cell culture parameters can help improve bioreactor productivity without sacrificing biologic product quality.

Speaker

Olivier R. Berteau, Global Pharmaceutical Industry Manager, METTLER TOLEDO Ingold

With a chemical engineering background, Olivier started his career working for the defense industry in the early 90s. It was during this period that he became interested in the design of PODs and modular systems. In 1992, under the guidance of Professor Henri Blachere, he designed, developed and worked intensively with bioreactors and fermenters. Since that time, he has been involved in the development of, and strategic new product introduction (NPI) initiatives for, several technologies for bioprocessing, including: hemoglobin of marine origin as an oxygen transporter for cell culture; multi-sensor measurements (5 parameters) in a 25 mm peak sphere moving freely in a bioreactor; capacitance; fully-automated fermentation at mini scale (BioPOD); and acoustic single-use perfusion.

It was in 2003, while continuing to apply the concept of POD, that he began to take an interest in the concepts of continuous manufacturing, drawing inspiration from a 1971 patent demonstrating the performance of continuous cultures of yeast for more than 9 months without inducing cross-contamination. In 2013, before joining METTLER TOLEDO, he patented a method in cell culture using scale-out concepts in combination with perfusion and more advanced management of analytical parameters during cell culture. Olivier has over 25 years of hands-on operating experience within the biopharmaceutical industry, with expertise in technology, technology development, and new product development for upstream bioprocessing.

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