A Next-Generation Plasmid Vector System
Read the FAQs on our next-generation plasmid vector system designed for cell and gene therapy applications. While answering the questions below, we cover reported therapeutic applications, their respective cell and gene editing modalities using Nanoplasmid, and any relevant resources and articles.
Nanoplasmid encompasses all the performance benefits (i.e. improved transfection efficiency, reduced cellular toxicity after transfection, and improved transgene expression) of minicircles without the problematic low-yield manufacturing and purity complications from long and complicated processes. To learn more about Nanoplasmid’s performance benefits, please download our whitepaper: Next Generation Plasmid Technology Improving Performance Safety and Manufacturing for Today’s Therapies.
Furthermore, Nanoplasmid’s antibiotic-free selection system is R6K strain-dependent, eliminating the chance of antibiotic resistance marker transfer to patients while reducing horizontal gene transfer seen in promiscuous pUC vector systems. If you would like to learn more about Nanoplasmid’s antibiotic-free selections system and how it can reduce your organization’s regulatory concerns, please read our whitepaper titled: Eliminated Antibiotic Resistance Gene Transfer Risks in Cell & Gene Therapies
When comparing Nanoplasmid to synthetic linear DNA, it has superior performance in transfection efficiency, and the manufacturing of synthetic DNA is also limited by its in vitro transcription error rate (generally around 100-1000 increased mutation rate) as compared to traditional plasmid propagation, which includes repair mechanisms (mismatch repair) that maintain high fidelity.
Many peer-reviewed articles and clients report lower cell death and improved transgene expression after transfection when using Nanoplasmid.
You can see our full, up-to-date list of featured publications by downloading our bibliography here.
AAV: Nanoplasmid’s proprietary host strain REVIVER® has been demonstrated to produce higher plasmid yields (~3-8 times) than a typical Stbl3 strain while maintaining or improving ITR integrity in plasmids used for AAV. Furthermore, REVIVER® is a non-mucoid culture that allows for improved downstream processing of the final product.
mRNA: Regarding mRNA template manufacturing, similarly to AAV, the REVIVER® host strain propagates constructs containing poly(A) tails while improving yield and maintaining or improving the structural DNA integrity.
Please visit our nanoplasmid page to initiate your inquiry. An Aldevron colleague will reach out to gather additional details such as the number of constructs, quantities of each construct, timelines, etc. S/he will provide additional information about the pricing and connect you with our scientific staff to start the design phase.
Aldevron respects, and does not ask for, sensitive information regarding your gene of interest (GOI) or additional details other than what is necessary for retrofitting/subcloning into the Nanoplasmid backbone. Generally, you should include two weeks for cloning and two weeks for production, not including the time required for gene synthesis as needed. Many partners request Aldevron’s standard Confidentiality Disclosure Agreement (CDA) before sharing details of their experiments. The Nanoplasmid constructs are shipped under a Limited Use Label License (LULL).
For clinical trials for indications in human or animal health, you may require GMP (or equivalent) quality-grade plasmid DNA (pDNA). We will connect you to the Aldevron sales team in your geographic area to evaluate your needs, such as quality level, quantity, timeline, price, and legal/regulatory documentation and support. With 25+ years of experience, you can rest assured that all your questions will be addressed.
Prior to initiating clinical trials, you will also require a clinical and commercial use license. We encourage you to reach out for a detailed discussion. While each license agreement is structured differently to accommodate your needs and requirements, a few common license elements include an upfront fee, maintenance fee, and success-based milestones.