Outsource Your Plasmid DNA Projects
We Have the Perfect Solution
The demand for plasmid DNA extends from vaccines and therapeutics in human and veterinary health sectors, to the diagnostics market including in vitro diagnostics (IVD) and medical imaging.
Our plasmid DNA platform offers advanced and custom manufacturing services, in Discovery, Research, High-Quality and GMP grades from microgram to gram scale, for use of supercoiled DNA as raw materials, drugs substances, or in linear form for mRNA applications. Whatever your usage, grade, or scale required, our robust plasmid manufacturing services ensure:
- High purity: Low endotoxin & high supercoiled
- Speed: Capacity available in short lead time
- Flexibility: Compatible with all types of plasmids & Variety of grades and volumes to meet your needs as you scale
- Regulatory Compliance: ICHQ7 GMP Facility, Eudralex vol.4 Part II, Antibiotic-free process, TSE/BSE Free
Discover Plasmid Applications
Sartorius offers scalable plasmid manufacturing using a consistent, optimized E. coli-based process across all quality grades—Discovery, Research, HQ, and GMP. Our platform supports high-yield production for various plasmid types (AAV, LV, mRNA, DNA vaccines) while ensuring quality.
Plasmid Grade Selection for Starting Material
Supercoiled DNA
Our service specializes in producing high-quality plasmids that serve as essential starting materials for viral vector manufacturing in cell and gene therapy applications such as AAV and LV. With a focus on achieving superior yields and maintaining the integrity of the supercoiled plasmid form, our process ensures that the plasmids meet the stringent requirements necessary for downstream applications. These plasmids are integral to the development of viral vectors, facilitating the advancement of innovative therapies in the field of cell and gene therapy.
Linearized DNA
Linearized plasmids, characterized by their high level of purity, are utilized for therapeutic applications including mRNA vaccines. We have optimized our DNA production and linearization process to ensure high production yield of linearized plasmids.
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Plasmid Grade Selection for Drug Substance
Our injectable GMP grade plasmids are manufactured following ICH Q7 guidelines and the Eudralex vol. 4 Part II standards, ensuring the highest safety for patients. These plasmids are suitable for use in DNA therapeutics and vaccines, supporting advanced applications in medical treatments and preventive healthcare.
Discover Our Plasmid Grades & Manufacturing Process
We use the same IP-free E. coli strain and process for our Research, High-Quality, and GMP plasmids. Our proprietary process was designed to ensure high production yield for any type of plasmid (AAV, LV, mRNA, DNA vaccine). With this approach, no additional process optimization is required when scaling up or transitioning to a higher quality grade, which saves time and costs.
We can also provide small scale plasmids preparation in Discovery grade, which is produced in an optimized" shake flask-based process to meet your requirements. For Research, HQ and GMP grade plasmids, feasibility studies are performed at the beginning of the project to maximize production yields according to each plasmid.
Need cell banking? We also offer banking services, including Glycerol, Research, and Master Cell Banks, and provide a Non-Animal Origin statement for all our products.
Learn more about our plasmid grades in the table below.
Quality Is in Our DNA
Our services include full-length sequence analysis using Next Generation Sequencing (NGS) or Sanger sequencing and a Certificate of Analysis for each batch of product. All our manufacturing and analytical batch records are supported with change control and environmental monitoring to ensure consistent quality.
The produced plasmids undergo extensive characterization and quality control testing. Traceability of raw materials and processes, as well as batch to batch consistency are assessed to ensure robustness and reproducibility.
Consult Our Experts
Learn more about quality and deliverables by grade in the table below.
FAQs - Plasmid Manufacturing Service
Submit your request using our contact us form. A first ballpark estimation will be rapidly sent to you. Based on the requested plasmid quantity and quality grade, a detailed quotation will be edited including the adapted strategy, the successive work packages and deliverables, the timing as well as the associated budget.
The turnaround time for the manufacturing of one R&D grade batch ranges between 4 and 6 weeks depending on the existence or not of a cell bank. The timing required for the manufacturing of a set of 4 plasmids will take between 9 and 11 weeks. Ten additional weeks are necessary for the release of one GMP batch.
The maximum quantity of plasmid that can be delivered is 20 g regardless of the quality grade considered (R&D, HQ or GMP) We also offer a pDNA amplification service for quantities up to 50 mg at a discovery grade
