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Related Experiment Videos

Cell banking.

M E Wiebe1, L H May

  • 1Genentech, Inc., South San Francisco, California.

Bioprocess Technology
|January 1, 1990
PubMed
Summary
This summary is machine-generated.

Master cell banks (MCBs) enable standardized biopharmaceutical production. Exhaustive characterization of these cryopreserved cell lines ensures high-quality products, surpassing traditional extraction methods.

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Cell Biology
  • Quality Control

Background:

  • Traditional biopharmaceutical production relies on biological extraction, leading to variability.
  • Cultured cells offer a more standardized approach to biopharmaceutical manufacturing.

Purpose of the Study:

  • To highlight the advantages of using master cell banks (MCBs) in biopharmaceutical production.
  • To emphasize the role of MCBs in achieving standardization and product quality.

Main Methods:

  • Utilizing diploid cell strains or continuous cell lines for biopharmaceutical production.
  • Cryopreservation of production cell lines to establish MCBs.
  • Exhaustive characterization of MCBs for adventitious and endogenous agents.
  • Development of assays to detect potential product contaminants.

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  • Validation of contaminant removal during purification through quality control.

    • Main Results:

    • MCBs provide a consistent and common starting material for biopharmaceutical manufacturing.
    • Comprehensive characterization of MCBs allows for rigorous safety assessments.
    • Validated purification processes effectively remove cellular contaminants.
    • Standardized processes using MCBs yield higher quality biopharmaceuticals.

    Conclusions:

    • Characterized cell banks are fundamental to standardizing biopharmaceutical manufacturing.
    • MCBs enable the production of high-quality biopharmaceuticals unattainable by traditional extraction methods.
    • The use of MCBs ensures product consistency and safety throughout the manufacturing lifecycle.