Feeding strategy optimization in interaction with target seeding density of a fed-batch process for monoclonal antibody production

نویسندگان

  • Marie-Françoise Clincke
  • Grégory Mathy
  • Laura Gimenez
  • Guillaume Le Révérend
  • Boris Fessler
  • Jimmy Stofferis
  • Bassem Ben Yahia
  • Nicola Bonsu-Dartnall
  • Laetitia Malphettes
چکیده

Background Current trend towards Quality by Design (QbD) leads the process development exercise towards systematic experimentation, rational development, process understanding, characterization and control. In this study, an example of the application of QbD approach is given. Optimization of the feeding strategy and the target seeding density was performed and interactions of the two parameters were assessed in order to enhance cell growth and MAb productivity. The feeding strategy was optimized to take into account daily process performance attributes and associated nutrient needs of the culture to maintain a balance between metabolism and MAb productivity. For scale up the feed strategy was simplified to become independent of daily process performance attributes. Feed ranging studies were performed to assess the robustness of the process.

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عنوان ژورنال:

دوره 7  شماره 

صفحات  -

تاریخ انتشار 2013