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Plasmid DNA Manufacturing

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Standalone or integrated plasmid DNA for research, preclinical and clinical applications

Precision Plasmids™: Quality you can trust

CBM Precision Plasmids™ are the highest quality plasmids manufactured with our platform process including sequence identify confirmation via Next Generation Sequencing (NGS) and are available for a wide range of applications- [R&D, Pro, and GMP grades]; and at different scales - as small as milligrams up to multi-grams - to meet your program needs at every stage of development . To reduce turnaround times (TAT) and accelerate your cell and gene therapy programs, we also offer pre-manufactured, off the shelf Precision Plasmids™.
Whether standalone as a source of drug substance or within an integrated Vector Manufacturing Solution™, advanced therapy companies can start development and manufacturing today.

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 segregated cell banking, upstream rooms, and downstream rooms 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™ 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 Precision Plasmids™ Pro mimic the key components of cGMP manufacturing but are a quicker, economical alternative to GMP plasmids for early-phase clinical trials and are designed for seamless transition to GMP for future clinical development. Our Precision Plasmids GMP grade (coming soon) are produced using CBM’s platform manufacturing process, platform analytics, and confirmed via NGS (15-20X higher sensitivity than traditional Sanger sequencing) to ensure each batch delivers the highest quality product.

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

Precision Plasmids™ GMP

  • Starting material for the manufacturing 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