Outsource Your Plasmid DNA Projects
We Have the Perfect Solution
The demand for plasmid DNA extends from vaccines and human therapeutics, Cell and Gene Therapy to veterinary health sectors.
Our validated plasmid DNA platform offers advanced and custom manufacturing services available at all grades and scales tailored to meet your requirements. With an extensive range of quality grades (Discovery, Research, GMP Principles and GMP) and multiple production scales (microgram up to gram production batches) our service enables the production of supercoiled or linear DNA as starting material or drug substance.
- High purity: Low endotoxin & high supercoiled content
- Speed: Short lead time for all quality grades
- 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 and animal free
Tailored DNA Supply for each Development Phase
For use as starting material to produce biotherapeutics such as mRNA and viral vectors, or as the final drug substance, our plasmid DNA platform ensures efficient and cost-effective manufacturing for every development phase. Our extensive range of available quality grades ensures reliable quality and compliance to cover regulatory requirements throughout preclinical, clinical, and commercial phases with Discovery, Research, GMP Principles, and GMP grade (certified manufacturing site).
Fast, Cost-Effective Plasmid Production for Early Research
Our Discovery grade material is produced using a cost-effective and flexible process, designed for early-stage research. Starting from as little as 1 µg and scaling up to 50 mg, this approach allows us to rapidly generate plasmids with short lead times of 3 to 4 weeks. Each batch is delivered with a detailed analysis report, giving you reliable data to support proof-of-concept studies and accelerate your decision-making in the discovery phase.
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Bridge Discovery to Research: Highly-Purified Plasmids for Advanced Research
Our Research grade material is manufactured following scalable bioreactor processes, using only one single chromatography step to reach specifications for release. This enables a large plasmid DNA production range from 50 mg up to 20 g, with a standard short lead time of 6 weeks. The Research grade is highly purified plasmid DNA that is provided with a comprehensive analysis report to support preclinical development and advanced research needs. Designed as a bridge between Discovery and GMP Principles grades, our Research grade material ensures consistent, scalable, and reliable performance for your next project stage.
From Research to GMP Principles : Scalable Plasmid Solutions for Development & Preclinical
GMP Principles – Small Scale (1 mg to 50 mg)
Our GMP Principles small-scale offering provides highly purified plasmids produced under controlled conditions, bridging the gap between Research and full GMP manufacturing. With batch sizes ranging from 1 mg to 50 mg and turnaround times from 5 to 8 weeks, this grade includes comprehensive documentation such as CoA, MSR, TSE/BSE-free statement, and on-site MBR. It is the ideal solution for method development, early toxicology studies, and process optimisation following GMP rules.- GMP Principles – Large Scale (50 mg to 20 g)
For projects requiring larger quantities, our GMP Principles large-scale service delivers from 50 mg up to 20 g within 10 weeks. Produced under GMP-like conditions, this grade ensures reproducibility and quality with extensive documentation including CoA, MSR, TSE/BSE-free statement, and on-site MBR. It is specifically designed to support preclinical and early phase clinical trials providing a reliable foundation for your transition to full GMP manufacturing.
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Achieve Clinical Excellence: GMP Certified Plasmids for Safe & Reliable Market Access
Our GMP grade offering implies manufacturing in full compliance with Good Manufacturing Practices at a certified manufacturing site, delivering plasmids at the highest quality standard for clinical and commercial phases. With scales from 200 mg up to 20 g and a standard lead time of 12 weeks, this grade includes a comprehensive documentation package: CoA, MSR, animal-free statement, GMP certificates, and on-site MBR. Designed to meet strict regulatory requirements, our GMP grade service ensures safety, consistency, and full traceability to support your clinical trials and your market access.
Quality Assurance
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. Our GMP Principles and GMP grade manufacturing and analytical batch records are supported with change control. Also, we ensure environmental monitoring to ensure consistent quality with our GMP grade.
The produced plasmids undergo extensive characterization and quality control testing. Traceability of raw materials and processes under QA oversight for GMP Principles and GMP grade.
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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 rapidly be 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 standard turnaround time for the manufacturing of one batch is as follows:
- Discovery: 3 to 4 weeks
- Research: 6 weeks
- GMP Principles: 5 to 10 weeks
- GMP: 12 weeks
The maximum quantity of plasmid that can be delivered is 20 g regardless of the quality grade considered (Research, GMP Principles Grade or GMP). We also offer a pDNA amplification service for quantities from 1 μg to 50 mg at Discovery grade.
