Our services
Plasmid DNA Platform
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.
Utilize our Research-grade, High-Quality (HQ), and GMP-grade plasmid DNA CDMO services across all stages of development. From pre-clinical research to commercial production.
- Research-grade:
- For technology establishment in rapid time scale
- First discovery and R&D phase
- High-Quality:
- For first clinical phase (phase I) with GMP-like manufacturing materials and methods
- GMP-grade:
- Produced in classified manufacturing suites following cGMP practices
- For Phase II and III
Our teams of skilled professionals are committed to guiding you through every step of your journey, from DNA sequence 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, we’re fully equipped to meet your specific needs.
Plasmid DNA Projects and Applications
Explore 3PBIOVIAN’s comprehensive Research-grade, High-Quality (HQ), and GMP-grade plasmid DNA services, supporting projects from early discovery to commercial production.
We offer rapid manufacturing of Research-grade plasmid DNA, ideal for discovery and preclinical programs, with flexible scales ranging from sub-liter to 5–10 L fermentations. Our High-Quality tier supports more advanced development at 20 L scale. For GMP applications, our flexible E. coli fermentation options ensure we can accommodate a wide range of project needs, from small-scale studies to late-phase manufacturing.
Our plasmids are well-suited for AAV-based gene therapy development and are an integral part of our AAVion® Platform, enabling a seamless transition from plasmid production to AAV manufacturing.
The plasmid DNA Platform also supports the development of DNA and mRNA vaccines, as well as non-viral gene therapy applications. With 3PBIOVIAN, you benefit from an end-to-end platform service, ensuring consistency and efficiency from plasmid design to aseptic Fill & Finish.
Viral Vector Production
DNA Vaccines
Cell and Gene Therapy
mRNA Vaccines
Plasmid DNA production
Our platform approach to Research-grade, High-Quality (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 are tailored to your product-specific requirements – from streamlined documentation for early discovery work to full GMP compliance for clinical and commercial use.
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 either via centrifugation or tangential flow filtration (TFF). Following this, intracellular plasmids are released through alkaline lysis of the cultured host cells. The AAV plasmids are then purified using chromatographic methods and undergo thorough analysis to verify their identity and purity. Additionally, E. coli master and working cell banks are generated for future use.
At 3PBIOVIAN, our in-house AAVion® platform is fully supported by a dedicated Plasmid Platform, enabling rapid and seamless AAV process development and manufacturing without delays or disruptions. The tight integration between plasmid production and AAV manufacturing ensures consistency, efficiency, and accelerated project timelines.
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.
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
