Abstract

Concept Production of biopharmaceuticals for diagnostic and therapeutic applications with suspension cells in bioreactors requires a seed train up to production scale [1]. For the final process steps in pilot and production scale the scale-up steps are usually defined (e.g. a factor of 5 10). More difficult in this respect are the first steps, the transitions between T-flasks, spinner tubes, roller bottles, shake flasks, stirred bioreactors or single-use reactors, because here often scale-up steps are different. The experimental effort to lay these steps out is correspondingly high. At the same time it is known that the first cultivation steps have a significant impact on the success or failure on production scale. The concept for a model based design of the seed train consists of the following steps:

Highlights

  • Model-based design of the first steps of a seed train for cell culture processes

  • Concept Production of biopharmaceuticals for diagnostic and therapeutic applications with suspension cells in bioreactors requires a seed train up to production scale [1]

  • The concept for a model based design of the seed train consists of the following steps: Two batch experiments were performed in shake flasks for determination of kinetic parameters

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Summary

Introduction

Model-based design of the first steps of a seed train for cell culture processes Concept Production of biopharmaceuticals for diagnostic and therapeutic applications with suspension cells in bioreactors requires a seed train up to production scale [1]. More difficult in this respect are the first steps, the transitions between T-flasks, spinner tubes, roller bottles, shake flasks, stirred bioreactors or single-use reactors, because here often scale-up steps are different. At the same time it is known that the first cultivation steps have a significant impact on the success or failure on production scale.

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