Research Grade, High Quality and GMP Plasmid DNA Manufacturing

Two scientists in protective gear work in a CDMO plasmid DNA manufacturing suite. One operates a control panel, while the other adjusts equipment on a large, stainless steel bioreactor system, designed for producing plasmid DNA at scale. Tubing, valves, and sensors emphasize precise, high-tech biopharmaceutical production.

GMP Plasmid DNA Manufacturing for Gene Therapy: Research Grade, High Quality, and GMP Production

Through leveraging Pharmaron’s proprietary gene therapy plasmid design and advanced plasmid DNA manufacturing technology, partners can simplify supply chains and take control over both the CMC development for their product and critical plasmid supply.

Pharmaron’s integrated Gene Therapy platform process is underpinned by expert scientific and regulatory knowledge, and our focus on quality allows our team to seamlessly deliver research, high-quality, and GMP-grade plasmid DNA to meet customer timelines.

Two scientists operate red ?KTA avant systems in a clean lab environment during plasmid DNA manufacturing procedures.

GMP and Research Grade Plasmid DNA Manufacture and Design

  • Access to Pharmaron’s Rep-Cap and Helper plasmids
  • Plasmid design and optimization
  • Targeted plasmid DNA manufacturing technology and process development for plasmid-specific optimization
  • Animal component free flexible platform production strategies to meet client needs
Scientists handle centrifuge components while preparing equipment for E. coli cell banking in a controlled lab setting.

E. coli Cell Banking

  • Production of research grade E.coli cell banks
  • Production of GMP E.coli cell master and working cell banks
Scientist pipettes orange cell culture medium into a flask during GMP release and stability testing in a sterile hood.

GMP Release and Stability Testing for Cell Banks and Plasmids

  • Grade appropriate documentation and release testing
  • Manufacture and testing of research grade non-GMP plasmid DNA
  • GMP manufacture of purified bulk plasmid, including testing and batch release
A close-up of a bioreactor filled with a yellow-orange solution, used in plasmid DNA manufacturing. The vessel is surrounded by tubing and sensors, highlighting precise control and monitoring during fermentation or purification processes. This setup ensures high-quality plasmid DNA production for therapeutic applications.

Plasmid DNA Manufacturing Capabilities

  • Range of fermenter scales (250mL to 300L)
  • High copy number plasmid DNA production
  • Single-use development technologies
  • Chromatography-based purification
  • Integrated analytical testing
  • Product characterization
  • Expertise in creation of critical starting materials
  • Dedicated microbial GMP processing suites
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