Plasmid DNA Manufacturing
CONNECT WITH AN EXPERTStandalone or integrated plasmid DNA for research, preclinical and clinical applications

Precision Plasmids™: Quality you can trust
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.

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.

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
Contact us to discuss how CBM’s integrated capabilities can support your program
Viral Vector Manufacturing
CBM’s viral vector platform efficiently and consistently delivers high yields in AAV, Lentivirus, HSV and Adenovirus vectors, accelerating the development of new therapies.
Cell Therapy Manufacturing
CBM has one of the cell therapy’s most experienced teams and the largest single site facility in the industry. There is no greater centralization of expertise.
Our Experienced Team
Our team brings a wealth of experience from biopharma and advanced therapy CDMOs, ensuring that there is no safer place for your product.