GMP – Grade Plasmid Manufacturing Facility

Plasmid DNA is the fundamental starting material behind innovative new therapies. Its quality, purity and regulatory compliance directly determine the success of clinical and commercial programs.

Through its GMP manufacturing facility, RD-Biotech can supply GMP-grade plasmids as starting materials for your innovative therapeutic applications, including cell therapies, gene therapies, and mRNA-based therapies and vaccines.

GMP-Grade Plasmid Bioproduction

Through its GMP manufacturing facility, RD-Biotech can supply GMP-grade plasmids as starting materials for your innovative therapeutic applications:

  • Gene therapy
  • Cell therapy
  • mRNA-based therapies

For the production of adeno-associated virus (AAV) vectors intended for gene therapy, plasmid quality is a key factor in the success of the manufacturing process.

A highly purified plasmid, predominantly in its supercoiled form and free from endotoxins and residual impurities, ensures efficient transfection and optimal expression of the Rep/Cap and Helper cassettes, as well as the vector containing the transgene of interest. Effective upstream control of plasmid quality directly results in higher viral yields, improved reproducibility and reduced batch-to-batch variability.

For clinical and commercial applications, plasmid quality also affects the safety of the final product. A controlled impurity profile reduces the risks of inflammation and immune activation while facilitating regulatory compliance. High-quality plasmids secure critical process stages (from transfection to viral purification) and facilitate scale-up.

Choosing the highest-quality plasmids produced by RD-Biotech ensures the performance of your AAV platform, accelerates development and improves the robustness of clinical-batch manufacturing.

In the production of lentiviral vectors used for cell therapies (including modified CAR-T, NK and iPSC cells) the quality of the plasmids used during transfection is a key factor.

High-quality plasmids with a very high proportion of supercoiled DNA and very low levels of endotoxins, residual genomic DNA and other impurities enable stable, coordinated expression of the gag/pol, rev, env and transfer plasmids.

Effective upstream control results in higher viral titers, improved reproducibility and reduced batch-to-batch variability.

For clinical and commercial applications, plasmid quality directly affects lentiviral-vector safety and process robustness. A well-controlled impurity profile reduces the risk of immune activation and residual contaminants while facilitating regulatory compliance.

Premium-grade plasmids also ensure consistent performance during critical stages—including transfection, production, clarification and purification—and support smooth scale-up from preclinical development to clinical and commercial batches.

Investing in high-quality plasmids strengthens the reliability of your lentiviral platform and secures your cell-therapy programs.

For mRNA-based applications, RD-Biotech supplies high-quality circular plasmids ready for linearization or plasmids already linearized according to customer specifications.

Linearized plasmids are the preferred templates for the in vitro transcription processes used to produce messenger RNA.

Our GMP batches are supplied with:

  • Restriction profiles
  • Sequence confirmation
  • Evidence demonstrating the absence of residual genomic DNA contamination

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