Our services

Plasmid DNA Services

Always close, we are with you all the way on your Plasmid DNA Production journey. Together, making advanced biologics, and tomorrow’s life-transforming therapies.

This is affinity in the making.

Always close, we are with you all the way on your Plasmid DNA Production journey // 3PBIOVIAN / Affinity in the making.

Utilize our High-Quality (HQ) and GMP plasmid DNA CDMO services across all stages of development – from pre-clinical research to commercial production.

Our specialist services in manufacturing plasmid DNA with a focus on viral vector manufacturing for gene therapies. Our GMP plasmid DNA is instrumental in developing innovative DNA or mRNA vaccines and non-viral gene therapy applications.

Our teams of skilled professionals are committed to guiding you through every step of your journey, from gene inception to the delivery of the final vialed product.

We adhere to the highest Good Manufacturing Practice (GMP) standards, ensuring quality consistency from raw materials to the final drug products. Our GMP-grade plasmid CDMO services not only guarantee regulatory compliance but also offer cost-effective solutions for a seamless transition to the next phase of your project. With our highly flexible solutions tailored to projects of various sizes, including E. coli fermentation options for GMP plasmid DNA production of up to 200 L, we’re fully equipped to meet your specific needs.

 


Always close, we are with you all the way on your Plasmid DNA Production journey // 3PBIOVIAN / Affinity in the making.

Plasmid DNA Projects and Applications

Explore 3PBIOVIAN’s comprehensive High-Quality (HQ) and GMP plasmid DNA services, covering all stages from pre-clinical research to commercial production. We specialize in manufacturing plasmid DNA, with a significant focus on viral vector production for gene therapies, utilizing our GMP-grade plasmid DNA as a crucial raw material. Additionally, our plasmid DNA is pivotal for developing innovative DNA or mRNA vaccines and non-viral gene therapy applications. We offer flexible solutions tailored to projects of various sizes, including E. coli fermentation options for GMP plasmid DNA production up to 200 L.

With 3PBIOVIAN, you benefit from an end-to-end plasmid DNA production service, ensuring consistency and efficiency from cell banking to aseptic Fill & Finish.

Viral Vector Production

DNA Vaccines

Cell and Gene Therapy

mRNA Vaccines

Plasmid DNA production

Our platform approach to HQ and GMP plasmid DNA production minimizes the time needed from project set-up to Drug Substance or Drug Product delivery. Quality control and documentation packages will be provided according to your product-specific requirements.

  • Research Cell Bank (RCB)
  • Master Cell Bank and Working Cell Bank (MCB/WCB)
  • Plasmid production in selected E. coli strain
  • Fermentation option up to 200 L
  • Harvesting by centrifugation / Tangential Flow Filtration (TFF)
  • Cell lysis
  • Chromatographic purification
  • Formulation by Tangential Flow Filtration (TFF)
  • Formulation
  • Fill and Finish
  • QC release testing
  • QP Certification and full GMP documentation
Always close, we are with you all the way on your Plasmid DNA Production journey // 3PBIOVIAN / Affinity in the making.

Production of AAV plasmids.

AAV plasmid production involves three distinct E. coli processes. First, bacterial cells are cultured under optimized growth conditions. Next, microbial cells are harvested via centrifugation. Following this, intracellular plasmids are released through alkaline lysis of the cultured host cells. The AAV plasmids are then purified using chromatographic methods. Finally, the purified plasmids undergo analysis to verify their identity and purity. Additionally, E. coli master and working cell banks are generated for future use.

QC tests for plasmids

We offer a range of QC services for plasmid DNA to assess the quality, purity, and stability of plasmid DNA samples. Our comprehensive tests confirm sequence integrity, purity analysis to detect impurities, concentration determination, size analysis for molecular integrity, and functional assays to assess biological activity.
We have a strong track record in supporting clients with regulatory-compliant documentation. The documentation packages for Plasmid DNA projects include the following:

  • TSE/BSE certificate
  • Certificate of Analysis
  • Certificate of GMP compliance
  • Comprehensive production summary report

With you all the way…

together, making advanced biologics, and tomorrow’s life-transforming therapies.

We deliver unparalleled end-to-end development and manufacturing services for all protein expression systems and viral vectors, both for Drug Substances and Drug Products, from pre-clinical to clinical development and commercial phases.

We support our customers wherever they are on their journey, from early-stage development to commercialization. We are passionate, precise, and always close, together, making advanced biologics and tomorrow’s life-transforming therapies.


Pre-Clinical

Phase I

Phase II

Phase III

Commercial