Custom Plasmid DNA Manufacturing

Custom Plasmid DNA Manufacturing

Aldevron delivers confidence

When working with plasmids, nothing is certain. Every plasmid is unique, from Nanoplasmid™ vectors to traditional plasmid constructs, variations in promoters, antibiotic resistance cassettes, secondary structures (such as ITRs) and differing copy numbers can lead to challenges scaling up to clinical or commercial production, etc.

Aldevron has been balancing the science and art of plasmid manufacturing for 25 years, generating 165,000 lots, 5,000 at clinical grade, and supporting multiple commercial programs. When working on complex cell, gene, and mRNA-based therapies and vaccines, rely on our experience with plasmid production, so you can focus developing therapies that can transform patients’ lives.

Supporting progress in multiple dimensions

Quality grades

Working with multiple partners can increase costs and risk delays with difficult and time-consuming technical transfers. Aldevron offers phase-appropriate quality grades – from research to full cGMP – that are purposefully designed as a pathway from research to potential clinical success and commercialization.

Supporting progress in multiple dimensions

Quality grade comparison
The Aldevron Process Research Grade GMP- Source cGMP
Screening for optimal growth conditions
Growth via shake flask or highfermentation
Alkaline Iysis
Chromatographic purification
Consistent manufacturing process
Certificate of Analysis (CoA)
E.coli master cell bank generation
Manufacturing summary report
TSE/BSE statement
Validated QA oversight
Development/engineering work prior to banking and growth
Validated changes control systems
Project specific master batch records
ISO classified production suites
Environmental monitoring

Production scale

Our plasmid DNA manufacturing happens across 3 different facilities , ranging from high-throughput, small scale preps (<1mg) for research and pre-clinical activities to hundreds of grams for commercial applications. Aldevron uses a variety of optimization tools to increase efficiency and reduce costs for the manufacturing needs of our partners. We utilize shake flasks and a variety of bioreactors, including single-use fermenters, to meet our clients’ needs throughout their journey. Roughly this translates to:

Production scale

Optimization tools

When working on basic research, plasmids are easy – transform, grow, lyse, bind, wash, and elute. When a plasmid is a critical raw material for a therapeutic or vaccine there’s quite a bit more to it. Cost control becomes a key factor. Increasing yield and/or reducing manufacturing runs can cut costs. Plasmid performance, for example increasing viral titers in viral vector applications, could further drive down costs. After 25 years, we have a full toolbox to optimize plasmid production, including but not limited to:

Standardized Products

Aldevron has created a suite of standardized, stocked products that can create efficiencies and move your project to clinical trials and commercialization more efficiently. From increased knowledge of production to streamlining/eliminating licensing concerns, standard products can simplify projects. Learn more in the Breakthrough Blog – The Benefits of Streamlining and Standardizing Plasmid DNA for Cell and Gene Therapies.

Viral Vector Plasmids

AAV & Lentiviral

Viral expression and helper plasmids that generate high-titer viral vectors for research and clinical production

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Cloning Backbones

Royalty and license free empty vectors that can be modified to fit your needs.

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DNA/RNA Reporters

Various constructs with fluorescent proteins to test performance or use as a control.

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When you start your research with us, you can travel one continuous path to finished product. We’ve designed and built facilities and capabilities to meet today’s needs, while continuing to build for tomorrow. Our most recent addition is LPN formulations, with our partners at Precision Nanosystems, and sterile fill finish capabilities to deliver drug product.

Breakthrough Campus Advance Campus Aldevron Madison Aldevron Lincoln
Fargo, ND Fargo, ND Madison, WI Lincoln, NE

Plasmid DNA, RNA, Protein manufacturing at cGMP & GMP-Source™ quality for clinical applications

GMP Facility: 259,000 SF

Plasmid DNA manufacturing for research applications; Process development

Facility: 45,000 SF

Protein manufacturing and process development for research and diagnostics

Facility: 52,000 SF

Nanoplasmid™ platform and cell line R&D

Facility: 6,500 SF

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Talk with our experts

Interested in working together or have questions about our products and services? Reach out to our client relations team to learn more about what we offer and how to get started on your next project.

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