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Plasmid DNA Manufacturing

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Standalone plasmid or integrated supply for cell & gene therapy manufacturing

center for breakthrough medicines plasmid dna manufacturing expert

The critical genetic foundation for cell and gene therapies

Plasmid DNA is a critical starting material for advanced therapies and mRNA synthesis, supporting their transfection to enable rapid advancement of the therapeutic product. CBM offers Precision Plasmids™ R&D, Pro (GMP-like), and GMP grades to reduce turnaround times (TAT) and accelerate the path to clinic for cell and gene therapy companies.
Whether standalone as a source of drug substance or within an integrated Genesis Vector Manufacturing Solution™, advanced therapy companies can start development and manufacturing today. Underpinned by cell banking, manufacturing, and testing at a single site, clients can expect TATs of 12 weeks from a GMP master cell bank or 17 weeks from a starting R&D plasmid.

Expertise and dedicated capacity for plasmid DNA

Our expertise includes plasmid design, full process development including scale-up and tech transfer, and phase-appropriate testing and analytical services for Precision Plasmids™ R&D Grade, Pro (GMP-like) and GMP grades. We also offer complete cell banking services and long-term stability programs for both plasmids and cell banks.

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 Precision Plasmids™ R&D plasmid, we have dedicated laboratories for Precision Plasmids™ Pro (GMP-like) production 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.

plasmid dna manufacturing machinery at the center for breakthrough medicines facility

Phase-appropriate manufacturing that optimizes quality

CBM employs a phase-appropriate manufacturing strategy for plasmid DNA. Our Precision Plasmids™ Pro are 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 Precision Plasmids™ R&D-grade 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.

center for breakthrough medicines gmp plasmid manufacturing expert

CBM offers three grades of Plasmid DNA for phase-appropriate use

Precision Plasmids™ R&D

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

Precision Plasmids™ Pro

  • 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)

Precision Plasmids™ GMP

  • Starting material for the manufacture of viral vectors for clinical and commercial use
  • Drug substance for mRNA and DNA vaccines and therapeutics
  • 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 (topology)
  • Residual Host Genomic DNA
  • Residual Host RNA
  • Residual Host Protein
  • ABS 260/280 Ratio Purity
  • DNA Homogeneity
  • Endotoxins
  • Residual Antibiotic
  • Bacteriophage Testing (lysogenic & lytic)

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

Method

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