CBM Precision Plasmids™ are available for phase appropriate use in preclinical studies through GMP starting material and drug product. On-demand at any scale – as small as milligrams up to multiple grams – accelerate your program at every stage of development. To reduce turnaround times and accelerate your cell and gene therapy programs, we also offer pre-manufactured, off the shelf Precision Plasmids™.
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Plasmid DNA CDMO Services
Expertise and Dedicated Capacity for Plasmid DNA
Custom Manufacturing
- • Precision Plasmids™ R&D grade offers quick turnaround time, enabled by a platform process suitable for R&D but scalable – with multiple development options including strain selection, media optimization, and resin screening, and other unit operation process development.
- • Precision Plasmids™ Pro offer the same platform process and analytics as cGMP manufacturing but are a quicker, economical alternative to GMP plasmids for early-phase clinical trials. Designed for seamless transition to GMP for future clinical development.
- • Precision Plasmids GMP grade (coming soon) are manufactured using CBM’s platform process and analytics.
Off-the-Shelf AAV and LV Plasmids
- • Speed and quality are of the essence in the race to deliver cell and gene therapies for patients. Precision Plasmids™ are guaranteed to be of the highest quality, confirmed via next generation sequencing (NGS).
- • Receive phase-appropriate starting material for AAV triple transfection or third generation LV manufacturing. Precision Plasmids™ :
- • Royalty free for research and clinical use
- • 85%+ supercoiled
- • 100% identity guaranteed via NGS
![Hex Off the shelf starting material](https://breakthroughmedicines.com/wp-content/uploads/2023/07/Hex-Off-the-shelf-starting-material.png)
Advanced Analytics
- • All plasmids are confirmed via NGS to ensure each batch delivers the highest quality product
- • Safety assays include USP Sterility <71> / Rapid Sterility, Bioburden, and USP Sterility <71> / Rapid Sterility
- • Identity via sequencing assays
- • Purity assays include 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)
- • Characterization assays for pH, Appearance, and Nucleic Acid Concentration
- Custom Manufacturing
-
Custom Manufacturing
- • Precision Plasmids™ R&D grade offers quick turnaround time, enabled by a platform process suitable for R&D but scalable – with multiple development options including strain selection, media optimization, and resin screening, and other unit operation process development.
- • Precision Plasmids™ Pro offer the same platform process and analytics as cGMP manufacturing but are a quicker, economical alternative to GMP plasmids for early-phase clinical trials. Designed for seamless transition to GMP for future clinical development.
- • Precision Plasmids GMP grade (coming soon) are manufactured using CBM’s platform process and analytics.
- Off-the-Shelf AAV and LV Plasmids
-
Off-the-Shelf AAV and LV Plasmids
- • Speed and quality are of the essence in the race to deliver cell and gene therapies for patients. Precision Plasmids™ are guaranteed to be of the highest quality, confirmed via next generation sequencing (NGS).
- • Receive phase-appropriate starting material for AAV triple transfection or third generation LV manufacturing. Precision Plasmids™ :
- • Royalty free for research and clinical use
- • 85%+ supercoiled
- • 100% identity guaranteed via NGS
- Advanced Analytics
-
Advanced Analytics
- • All plasmids are confirmed via NGS to ensure each batch delivers the highest quality product
- • Safety assays include USP Sterility <71> / Rapid Sterility, Bioburden, and USP Sterility <71> / Rapid Sterility
- • Identity via sequencing assays
- • Purity assays include 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)
- • Characterization assays for pH, Appearance, and Nucleic Acid Concentration
Plasmid testing and analytical services
Safety Testing
Assay
- • USP Sterility <71> / Rapid Sterility
- • Bioburden
- • Mycoplasma Contamination
Method
- • USP <71> Direct Inoculation or BacT Alert
- • USP <61>
- • Quantitative PCR, dPCR or ddPCR
Identity Testing
Assay
- • Identity
- • Sequencing
Method
- • Restriction digest
- • Sanger or Next Generation Sequencing
Purity Testing
Assay
- • DNA Homogeneity (topology)
- • Residual Host RNA
- • ABS 260/280 Ratio Purity
- • Endotoxins
- • Bacteriophage Testing (lysogenic & lytic)
- • Residual Host Genomic DNA
- • Residual Host Protein
- • DNA Homogeneity
- • Residual Antibiotic
Method
- • HPLC, Capillary Gel Electrophoresis
- • Agarose Gel, HPLC
- • UV Spectrophotometry
- • USP <85>
- • Quantitative PCR, dPCR or ddPCR
- • Micro BCA, ELISA
- • Capillary gel electrophoresis
- • ELISA, Mass Spectrometry
Characterization Testing
Assay
- • pH
- • Nucleic Acid Concentration
- • Appearance
Method
- • USP <791>
- • A260 or HPLC
- • Visual Inspection
CBM Thought Leadership
![Line 20](https://breakthroughmedicines.com/wp-content/uploads/2023/01/Line-20.png)
Plasmid Manufacturing to Accelerate Advanced Therapies
This webinar will provide best-in-class strategies for plasmid development & manufacturing to accelerate advanced therapies from bench to bedside.
![Line 20](https://breakthroughmedicines.com/wp-content/uploads/2023/01/Line-20.png)
Proven Plasmid Platform Process
Developed via extensive DoE studies, CBM’s plasmid manufacturing platform delivers optimum process parameters for production of varying plasmid types. This results in over 95% supercoiled topology (compared to 80% industry) and endotoxin levels 32X lower than FDA regulatory guidance. In addition, plasmid identity is guaranteed via next generation sequencing.
Interested in discussing an upcoming plasmid DNA manufacturing program?
![Line 20](https://breakthroughmedicines.com/wp-content/uploads/2023/01/Line-20.png)