Plasmid DNA

The next quality level of plasmid DNA: from research to GMP manufacturing

Employe using a centrifuge

PlasmidFactory offers tailored amplification and purification of your plasmid constructs — based on fully defined sequences or ready-to-use vectors supplied by you. We focus on high-fidelity replication, scalable fermentation, and proprietary purification to deliver reproducible plasmid DNA from basic research applications to (pre-)clinical and GMP manufacturing.

What differentiates PlasmidFactory: As an independent European CDMO with 25+ years of DNA manufacturing expertise and a 99.9% success rate, we combine high-fidelity E. coli amplification, proprietary purification, and precise topology control to consistently deliver highly pure, predominantly supercoiled plasmid DNA — from Research Grade to full GMP.

Through pre-order consultations, we assess your technical and regulatory requirements to match the appropriate quality grade and production scale. All quality grades are available in scalable production formats, ensuring a seamless transition from early research to advanced therapeutic development.

Our Scientific Quality Grade supports advanced research applications, High Quality (HQ) Grade provides EMA-guideline-based material for preclinical and early clinical programs, and GMP Grade enables late-stage clinical development and commercial supply. These grades are optimized for demanding applications such as cell and gene therapy, viral vector production (e.g., AAV and LVV), vaccination approaches (including mRNA template production), genome editing, protein expression, and beyond.

Technologies such as POLYARESCUE® further enhance construct stability by protecting long poly(A) elements, supporting reliable downstream processing and consistent performance in therapeutic workflows, while additional proprietary technologies such as ITRPROTECT® and ITRRESCUE® enable the preservation, analysis, and restoration of sensitive ITR sequences for advanced AAV applications. We also offer plasmid linearisation services as well as support for cloning, gene synthesis, and sequencing — enabling seamless transition from construct design to scalable plasmid manufacturing.

As the cell and gene therapy market continues to expand, the need for robust and regulatory-aligned plasmid DNA manufacturing increases. PlasmidFactory supports biopharmaceutical partners and CDMOs with scalable, high-purity pDNA production, precise topology control, and efficient removal of host cell impurities — helping accelerate genetic medicine programs from early development to clinical and commercial manufacturing.

Our quality grades

Scalable plasmid and Minicircle DNA — from research to clinical manufacturing.

PlasmidFactory offers clearly defined quality grades to support every stage of your project — ensuring regulatory alignment, performance consistency, and seamless scale-up within one trusted CDMO.

Scientific Quality (SQ) Grade

Advanced research standard

  • Research Grade – reliable DNA for routine and advanced laboratory applications
  • CCC Grade – ≥95% supercoiled DNA for performance-critical and topology-sensitive workflows

High Quality (HQ) Grade

Highest non-GMP standard

  • EMA guideline-based manufacturing with validated methods and full traceability
  • Ideal for preclinical and early clinical starting material
  • Also available as HQ in GMP: produced in dedicated GMP facility using end-to-end single-use processes

GMP Grade

Clinical & commercial compliance

  • Manufactured in a dedicated EU GMP (Annex 1 & 2) compliant facility
  • End-to-end single-use USP & DSP processes and in-house QP release
  • Various fill & finish options
  • Designed for late-stage clinical trials and commercial supply

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