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Plasmid DNA Manufacturing

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Integrated manufacturing supporting cell and gene therapies.

Photo of a CBM Plasmid DNA manufacturing team member using a microscope at the facility for R&D and GMP plasmid production

The critical genetic foundation for advanced therapies

Plasmid DNA is a critical raw material for advanced therapies and mRNA synthesis, supporting their transfection to enable rapid advancement of the therapeutic product. Center for Breakthrough Medicines (CBM) offers capacity dedicated to the development and manufacture of high quality plasmid DNA and other nucleic acids.
Our expertise includes plasmid design, full process development including scale-up and tech transfer, and phase-appropriate testing and analytical services for R&D Grade, GMP-Like and GMP applications. In addition to our core process development, manufacturing, and testing capabilities, we also offer complete cell banking services and long-term stability programs for both plasmids and cell banks.

Dedicated capacity for Plasmid DNA

A key differentiator for CBM is our integrated end-to-end single site facility with all related development, manufacturing, and analytics occurring on one campus. In addition to our process development laboratory, capable of producing R&D grade plasmid, we have dedicated laboratories for GMP-Like production of plasmid DNA and other nucleic acids, with a segregated cell banking room, three segregated upstream rooms up to 50L scale, and one downstream room with closed processing.

GMP production will be supported by a 20,000+ square foot facility with upstream capabilities up to 200L fermentation, harvest and purification suites, as well as a dedicated formulation suite. Support operations include a day warehouse, media and buffer preparation suites, cold chain storage, and Quality Control (QC) testing laboratories.

Photograph of plasmid DNA manufacturing machinery at CBM's dedicated end-to-end CDMO facility for development, manufacturing and analytical capabilities

Phase-appropriate manufacturing that optimizes quality

CBM employs a phase-appropriate manufacturing strategy for plasmid DNA. Our GMP-like plasmid is a quicker, economical source for the quality and safety needed for early-phase clinical trials, designed for seamless transition to GMP for future clinical development. Our R&D-grade Plasmid DNA offers a quick turnaround time, enabled by a platform process and cell line suitable for R&D but scalable – with multiple development options including cell line selection, media optimization, and resin screening, and other unit operation process development.

Our Process Development team can assist with Plasmid Vector Design and Gene Synthesis. All plasmid projects begin with an E.coli host strain evaluation (DH1, DH5a, Stbl3 + other lines available) to determine the optimal conditions for each plasmid of interest. Depending on the grade requested by our client, we proceed to generate a Research Cell Bank (RCB) or GMP Master Cell Bank (MCB) and Working Cell Bank (WCB), followed by manufacture using our platform process, which is based on alkaline lysis and chromatographic purification.

Image of a team member wearing protective equipment whilst working with the production of plasmid DNA for cell and gene therapies in King of Prussia, Pennsylvania

CBM offers three grades of Plasmid DNA for various uses

R&D-Grade Plasmid DNA

  • Research & development
  • Process Optimization available to increase yield (2L-10L scale)
  • Pre-clinical toxicology studies
  • High throughput screening

GMP-Like Plasmid DNA

  • Starting material for the manufacture of viral vectors for clinical use
  • Starting material for mRNA manufacture
  • Process Optimization available to increase yield (10L-50L scale)

GMP-Grade Plasmid DNA

  • Starting material for the manufacture of viral vectors for clinical and commercial use
  • Drug substance for DNA vaccines
  • Process Optimization available to increase yield (50L-200L scale)

Plasmid testing and analytical services

Safety Testing

Assay

  • USP Sterility <71> / Rapid Sterility
  • Mycoplasma Contamination
  • Bioburden

Method

  • USP <71> Direct Inoculation or BacT Alert
  • Quantitative PCR, dPCR or ddPCR
  • USP <61>

Identity Testing

Assay

  • Identity
  • Sequencing

Method

  • Restriction digest
  • Sanger or Next Generation Sequencing

Purity Testing

Assay

  • DNA Homogeneity
  • Residual Host Genomic DNA
  • Residual Host RNA
  • Residual Host Protein
  • ABS 260/280 Ratio Purity
  • DNA Homogeneity
  • Endotoxins
  • Residual Antibiotic

Method

  • HPLC, Capillary Gel Electrophoresis
  • Quantitative PCR, dPCR or ddPCR
  • Agarose Gel, HPLC
  • Micro BCA, ELISA
  • UV Spectrophotometry
  • Capillary gel electrophoresis
  • USP <85>
  • ELISA, Mass Spectrometry

Characterization Testing

Assay

  • pH
  • Appearance
  • Nucleic Acid Concentration
  • Nucleic Acid Concentration

Method

  • USP <791>
  • Visual Inspection
  • A260
  • HPLC