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Related Experiment Videos

Recent trends in cell substrate considerations for continuous cell lines.

A S Lubiniecki1, J C Petricciani

  • 1GlaxoSmithKline R&D, 709 Swedeland Road, 19406, King of Prussia, PA, USA. anthony.lubiniecki@sbphrd.com

Current Opinion in Biotechnology
|June 19, 2001
PubMed
Summary
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The use of continuous cell lines (CCLs) in biological product manufacturing is debated. Decades of regulatory approvals demonstrate the safety and efficacy of products derived from CCLs.

Area of Science:

  • Biotechnology
  • Pharmaceutical Manufacturing
  • Vaccinology

Background:

  • The safety assessment of biological products involves ongoing debate regarding the use of continuous cell lines (CCLs).
  • Numerous recombinant DNA products and viral vaccines manufactured using CCLs have received regulatory approval since 1987.
  • Previous approvals followed thorough reviews of product safety and manufacturing processes.

Purpose of the Study:

  • To address the ongoing debate on the appropriateness of using CCLs for biological product manufacturing.
  • To evaluate the safety and regulatory considerations for using CCLs in the production of novel vaccines and protein products.

Main Methods:

  • Review of historical regulatory approvals for products derived from CCLs.
  • Analysis of safety and manufacturing data for approved biological products.

Related Experiment Videos

  • Examination of current discussions on CCLs for purified protein subunit vaccines (e.g., HIV) and human protein products.

    • Main Results:

    • Dozens of purified recombinant DNA products from CCLs have been approved.
    • Several live attenuated and inactivated viral vaccines manufactured in CCLs have also received regulatory approval.
    • The discussion continues regarding the use of human and non-human CCLs for purified protein subunit vaccines and products.

    Conclusions:

    • The use of CCLs in biological product manufacturing has a history of successful regulatory approval.
    • Rigorous safety and manufacturing reviews support the use of CCLs for diverse biological products.
    • Further evaluation is ongoing for specific applications like purified protein subunit vaccines using human CCLs.