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™.
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
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
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.
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?