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Research Grade, High Quality and GMP Plasmid DNA Manufacturing

Two scientists in protective gear work in a CDMO plasmid 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.

Research Grade, High Quality and GMP Plasmid DNA Manufacturing

Through leveraging Pharmaron’s proprietary gene therapy plasmid design and technology 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 seamlessly deliver research, high quality and GMP-grade plasmids to meet customer timelines.

Capabilities

Research Grade, High Quality and GMP Plasmid DNA Manufacturing
Viral Vector Process Development
Product Characterization and QC Analytics
GMP Manufacture and QP Release
Regulatory Dossier Authoring and Specification Justification
Connect with a Scientific Expert
A scientist operates a Sartorius Biostat system in a lab, managing the production of plasmid DNA. The advanced bioreactor setup, with precise controls and tubing, indicates research-grade and GMP-compliant plasmid DNA manufacturing, ensuring high-quality standards for therapeutic or vaccine development.

GMP and Research Grade Plasmid Manufacture

  • Access to Pharmaron’s Rep-Cap and Helper plasmids
  • Plasmid design and optimization
  • Plasmid-specific optimization through targeted process development services
  • Animal component free flexible platform production strategies to meet client needs
Two scientists in protective gear work in a clean lab. One adjusts equipment on a benchtop centrifuge, while the other handles a pipette. Both wear masks, gloves, and safety goggles, emphasizing sterile techniques.

E. coli Cell Banking

  • Production of research grade E.coli cell banks
  • Production of GMP E.coli cell master and working cell banks
Scientists in a lab work on plasmid DNA manufacturing processes. One operates an ÄKTA system for purification, while another reviews documentation, ensuring compliance with research-grade and GMP standards. The organized, sterile environment emphasizes precision and quality control.

GMP Release and Stability Testing for Cell Banks and Plasmids

  • Grade appropriate documentation and release testing
  • Manufacture and testing of research grade non-GMP plasmids
  • 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.

Capabilities

  • Range of fermenter scales (250mL to 300L)
  • High copy number plasmid 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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