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Related Experiment Videos

Effects of fermentation on product consistency.

A S Lubiniecki1, K Anumula, J Callaway

  • 1SmithKline Beecham Pharmaceuticals, King of Prussia, PA 19406.

Developments in Biological Standardization
|January 1, 1992
PubMed
Summary

Producing protein-based biopharmaceuticals using genetically engineered Chinese hamster ovary (CHO) cells requires robust process design and quality control. Despite potential variations during extended fermentation, consistent purity and potency of therapeutic proteins like soluble CD4, tPA, and EPO were achieved.

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Area of Science:

  • Biotechnology
  • Biopharmaceutical Manufacturing
  • Cell Culture Technology

Background:

  • Cell culture fermentation is crucial for producing protein-based biopharmaceuticals.
  • Genetically engineered Chinese hamster ovary (CHO) cells are widely used for recombinant protein production.

Purpose of the Study:

  • To evaluate the consistency of biopharmaceutical production using CHO cells under various fermentation conditions.
  • To assess the impact of extended fermentation and cell age on product quality and genetic stability.

Main Methods:

  • Genetically modifying CHO cells to produce recombinant human soluble CD4, tissue plasminogen activator (tPA), and erythropoietin (EPO).
  • Conducting extended perfused fermentations and evaluating genetic stability, potency, purity, and structural attributes of the products.

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  • Implementing process design, validation, and in-process quality control assays.

    • Main Results:

    • Extended fermentation of soluble CD4 showed some quantitative loss in DNA copy, mRNA expression, and titer, with a novel contaminant appearing in later harvests. However, final product purity and potency remained consistent.
    • Genetic stability evaluations for tPA revealed no significant effects of cell age on biological traits, potency, purity, or structure.
    • Erythropoietin (EPO) production demonstrated consistent lot-to-lot quality in genetically determined and process-determined traits, including potency, tryptic peptide mapping, and sialylation.

    Conclusions:

    • Robust process design, validation, and stringent quality control measures are essential for ensuring consistent recombinant protein production from cell culture fermentations.
    • CHO cell-based biopharmaceutical manufacturing can reliably produce high-quality protein therapeutics despite challenges in extended culture processes.