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Related Experiment Videos

Manufacturing and quality control of plasmid-based gene expression systems.

Eastman1, Durland

  • 1Gene Logic Inc., 10150 Old Columbia Road, Columbia, MD 21046, USA

Advanced Drug Delivery Reviews
|June 6, 2000
PubMed
Summary

DNA plasmid technology shows promise for treating diseases and for DNA vaccination, with established regulatory pathways. Manufacturing and characterization methods are advancing, enabling multi-gram production for pharmaceutical use.

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Area of Science:

  • Biotechnology
  • Molecular Biology
  • Pharmaceutical Science

Background:

  • DNA plasmid-based gene expression systems are under investigation for therapeutic applications and DNA vaccination.
  • Human clinical trials are ongoing for plasmid-based drugs, indicating significant therapeutic potential.

Purpose of the Study:

  • To review current manufacturing and characterization methods for pharmaceutical-grade DNA plasmids.
  • To discuss the evolving regulatory landscape for plasmid-based therapeutics.

Main Methods:

  • Adaptation of techniques from large-scale protein purification and molecular biology for plasmid production.
  • Characterization methods focus on ensuring high purity (≥95%) and quality for pharmaceutical applications.

Main Results:

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  • Multi-gram quantities of high-purity plasmids are achievable with current technologies.
  • The regulatory framework for biologicals is applicable to plasmid-based drugs, with FDA recognition.

Conclusions:

  • Current manufacturing and characterization techniques support the pharmaceutical development of DNA plasmids.
  • Further advancements in production and analytical methods are necessary for future drug development and marketing.