Release testing of retroviral vectors and gene-modified cells.

Diana Nordling, Anne Kaiser, Lilith Reeves

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

This chapter will review the design and execution of release testing requirements for retroviral vectors and gene-modified cells consistent with ensuring the success of the clinical trial on the basis of current US regulatory requirements. It is the ethical and legal responsibility of the clinical trial sponsor(s) to ensure safety of the patients through proper evaluation of the drug products prior to use. Any clinical trial drug product used in human subjects must be produced and evaluated for safety, quality, purity, and effectiveness according to Current Good Manufacturing Practices appropriate for the stage of clinical development.

Original languageEnglish (US)
Pages (from-to)265-279
Number of pages15
JournalMethods in molecular biology (Clifton, N.J.)
Volume506
StatePublished - 2009
Externally publishedYes

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Clinical Trials
Genes
Drug Evaluation
Patient Safety
Safety
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Molecular Biology
  • Genetics

Cite this

Release testing of retroviral vectors and gene-modified cells. / Nordling, Diana; Kaiser, Anne; Reeves, Lilith.

In: Methods in molecular biology (Clifton, N.J.), Vol. 506, 2009, p. 265-279.

Research output: Contribution to journalArticle

Nordling, Diana ; Kaiser, Anne ; Reeves, Lilith. / Release testing of retroviral vectors and gene-modified cells. In: Methods in molecular biology (Clifton, N.J.). 2009 ; Vol. 506. pp. 265-279.
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