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GMP-Grade Plasmid DNA Production

Biovian offers premium plasmid DNA CDMO services for preclinical, clinical and commercial production. In our Plasmid DNA production, we adhere to the same GMP standards from the starting material to the final drug products. The benefit of choosing a GMP-grade, yet cost-effective, plasmid CDMO from the start, lies in the smooth regulatory transition to the next steps. You can count on our skilled and passionate personnel to find the most suitable path and to guide you through your journey from gene to final vialled product.

Plasmid DNA Projects

Biovian manufactures plasmid DNA for a variety of client projects. One of our main focus areas is Viral Vector manufacturing for those gene therapies, where plasmid DNA constructs serve as key raw material. Our GMP plasmid DNA may also be used to develop novel DNA or mRNA Vaccines and non-viral Gene Therapy applications.

Plasmid DNA applications

  • Viral Vector production (e.g. AAV, Lentivirus)
  • Cell and gene therapy
  • DNA Vaccines
  • mRNA production

Plasmid DNA Production

We have the flexibility to deal with Plasmid DNA projects of various sizes. The options for E. coli fermentation for GMP plasmid DNA production extend up to 200 L.

One-Stop-Shop CDMO for Plasmid Manufacturing 

By choosing a One-Stop-Shop GMP plasmid DNA production service you get the benefit of having only one supplier – Biovian – through the entire process development and manufacturing assignment, from GMP Cell Banking to aseptic Fill and Finish. Our turn-key approach to plasmid DNA production minimizes the time needed from project set-up up to Drug Substance or Drug Product delivery. Quality control and documentation packages will be provided according to your product specific requirements.

Cell Banks 

  • Research Cell Bank (RCB)
  • Master Cell Bank and Working Cell Bank (MCB/WCB)

Upstream Processes

  • Plasmid production in selected E. coli strain
  • Fermentation option up to 200 L
  • Harvesting by centrifugation / Tangential Flow Filtration (TFF)
  • Cell lysis

Downstream Processes

  • Chromatographic purification
  • Formulation by Tangential Flow Filtration (TFF)

Aseptic Fill and Finish

  • Formulation
  • Fill and Finish

Quality Assurance and Quality Control

  • QC release testing
  • QP Certification and full GMP documentation

Plasmid QC Test Package Example

The QC tests include e.g. the following:

  • Appearance
  • pH
  • DNA concentration and purity
  • Total Plasmid purity
  • Identity
  • Supercoiled DNA purity
  • Residual host cell protein
  • Residual host cell DNA
  • Residual host cell RNA
  • Residual reagents
  • Bioburden and sterility
  • Endotoxin
  • Sequence

Plasmid QA Documentation Package Example

Biovian has a strong track record in supporting clients with regulatory-compliant documentation. The documentation packages for Plasmid DNA projects include e.g. the following:

  • TSE/BSE certificate
  • Certificate of Analysis
  • Certificate of GMP compliance
  • Comprehensive batch-manufacturing report
Microbial Production
Next step

Microbial Biopharmaceutical CDMO

Our clients will be offered a true One-Stop-Shop GMP CDMO service in microbial biologics production, with modular services available across the supply chain and across the value chain.

Contact Us

Antti Nieminen
Director, Business Development and Projects
Eero Mustalahti
Manager, Sales and Business Development