Plasmid Development and Manufacture

Through leveraging Pharmaron’s Gene Therapy plasmid development and in-house manufacturing capabilities, partners can simplify supply chains and take control over both the CMC development for their product and critical plasmid supply. Pharmaron’s Gene Therapy platform process is underpinned by expert scientific and regulatory knowledge and our focus on quality allows our team to deliver research and GMP grade plasmid.

View as PDF: Plasmid Development and Manufacture

Services

  • Plasmid-specific optimisation through targeted process development services
  • Animal component free flexible platform production strategies to meet client needs
  • Grade appropriate documentation and release testing
  • Manufacture and testing of research grade non-GMP plasmids (up to 0.3 g per batch)
  • Production of GMP E. coli cell master and working cell banks to ensure process consistency
  • GMP manufacture of grams of purified bulk plasmid, including release testing and batch release
  • Dedicated microbial GMP processing suites
  • Expertise in critical starting materials

Capabilities

  • Plasmid design and optimization
  • High copy number plasmid production
  • Single-use development technologies
  • Chromatography-based purification
  • Range of fermenter scales (250mL to 300L)
  • Integrated analytical testing
  • Product characterization
  • cGMP production and release testing
  • Stability testing for plasmids

 

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