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Cells, science and health.

J C Petricciani1

  • 1National AIDS Program, U.S. Public Health Service, Washington, D.C.

Developments in Biological Standardization
|January 1, 1989
PubMed
Summary
This summary is machine-generated.

Mammalian cell substrates for biological products have faced historical controversies. Lessons from human diploid cell debates inform the current acceptance of continuous cell lines for manufacturing, supported by modern safety processes.

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Area of Science:

  • Biotechnology
  • Cell Biology
  • Regulatory Science

Background:

  • Historical debates surrounding mammalian cell substrates for human biological product manufacturing began in 1954.
  • Controversies arose in the 1960s (human diploid cells) and 1980s (continuous cell lines) regarding the use of "abnormal" cell substrates as alternatives to primary cell cultures.

Observation:

  • The need for human interferon in the 1970s spurred the use of human lymphoblastoid cells, challenging previous restrictions.
  • The advent of recombinant DNA technology in the 1980s intensified discussions on the acceptability of continuous cell lines for product development.

Findings:

  • A 1986 World Health Organization Study Group reviewed safety issues concerning continuous cell lines, particularly for vaccines.
  • The study group recommended pursuing continuous cell lines for product development, citing modern manufacturing's ability to manage potential contaminants.

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Implications:

  • Historical controversies and lessons learned from human diploid cell use provide context for current regulatory considerations of continuous cell lines.
  • The acceptance of continuous cell lines, supported by international consensus and technological advancements, facilitates the production of a wider range of human biologicals.