Robust GMP plasmid manufacturing platform with extensive experience releasing GMP plasmids that meet the highest regulatory standards.
uBriGene supports R&D, preclinical, and GMP plasmid manufacturing with our optimized platform for high yield and quality. The GMP plasmid manufacturing services include tech transfer, process and analytical method development, and GMP manufacturing.
The plasmid DNA manufacturing services include tech transfer using our qualified E. Coli strains, E. Coli cell banking, process and analytical method development, and GMP manufacturing in compliance with the highest regulatory standards. uBriGene has released hundreds of GMP plasmid lots using in-house and custom quality and stability indicating methods. In addition to custom plasmid manufacturing service, we also have in-stock GMP grade AAV and Lentiviral vector packaging plasmids to support your viral vector needs.
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Talk To The Plasmid Expert
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uBriGene also provides cell banking services for GMP plasmid manufacturing. Full quality release assays and stability studies will be performed in house. PCB, MCB and WCB are established to meet Investigational New Drug application standards. View details at Cell Banking Services page.
Our GMP plasmid manufacturing platform is optimized for quality and yield. The closed and continuous alkaline lysis system ensures a high level of sterility and compliance with regulatory standards.
The lysates are clarified through scalable, fully closed depth filtration, followed by a cost-effective two-step purification process using anion exchange (AEX) and hydrophobic interaction chromatography (HIC). For larger-scale production membrane matrix chromatography allows for higher flow rates.
The advantages of membrane matrix in downstream chromatography for plasmid purification include requiring only 30% of the time compared to conventional resin. Therefore, plasmid DNA is manufactured faster and at a much lower cost.
The lysates are clarified through scalable, fully closed depth filtration, followed by a cost-effective two-step purification process using anion exchange (AEX) and hydrophobic interaction chromatography (HIC). For larger-scale production membrane matrix chromatography allows for higher flow rates.
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Request a quoteAs a one-stop plasmid DNA manufacturing CDMO, we provide the highest quality QA and QC support. Most of the plasmid QC release assays are performed in-house. Additionally, our dedicated and experienced quality teams can assist clients in developing analytical methods tailored to their specific needs.
| Test Items | Method | |
|---|---|---|
| Appearance | Visual inspection | |
| pH | pH measurement | |
| Concentration | UV, Spectrophotometry | |
| Identity | Restriction analysis | Gel electrophoresis |
| Target sequence analysis* | Sanger sequencing | |
| Purity | A260/A280 | UV, Spectrophotometry |
| Supercoiled plasmid ratio | HPLC | |
| Residuals | Residual E. Coli DNA | qPCR |
| Residual E. Coli RNA | Gel electrophoresis/HPLC | |
| Residual E. Coli protein | ELISA | |
| Safety | Endotoxin | Gel-clot assay |
| Sterility | Membrane filtration method | |
*Outsourced testing
| Membrane Chromatography | Conventional Resin | |
|---|---|---|
| TFF Duration | Not needed | 8.0 h |
| Volume, Membrane/Resin | 115 ml | 800 ml |
| Binding Capacity | ~10 mg/ml | ≤1.5 mg/ml |
| Flow Rate | 1.1 LPM | 0.16 LPM |
| Chromatography Duration | 2.9 h | 7.5 h |
| Cost | 30% | 100% |
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Request a quoteExplore uBriGene’s robust GMP plasmid manufacturing process and testing capabilities.
Unveil the current manufacturing approaches for LVV and its deployment in cell therapies.
Discover our AAV manufacturing capabilities, scalable processes, testing platform.
Yes, we provide plasmid production suited for the phase appropriate needs of your therapeutic programs. We can help with research grade, high quality, and full GMP plasmid manufacturing.
The estimated timeline for GMP plasmid manufacturing is about two to three months before QC testing, starting from microbial master cell banking.
uBriGene’s GMP plasmid production capability is up to 200L.
We have successfully produced 300+ GMP plasmid batches.
Yes, we can manufacture a variety of DNA, including circular plasmids, single-stranded DNA, linear DNA (template for mRNA production), linear closed-end DNA (more stable, mainly as gene editing donor template DNA), and minicircle DNA.
Ask the plasmid DNA expert! With over 300 GMP batches in our track record and our cost-effective platform technology, we can help accelerate your clinical programs.
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Request a Quote
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Ask the plasmid DNA expert! With over 300 GMP batches in our track record and our cost-effective platform technology, we can help accelerate your clinical programs.
Optional caption section: This caption text can be used under any image or content block as-needed. Use cases are figure legends, citations, image descriptions
Sit faucibus praesent in id natoque porta amet amet. Feugiat ullamcorper habitasse aliquet ante pharetra vitae eu morbi amet. Nunc eu leo lorem dignissim aliquet.
Sit aliquam elit vitae bibendum lectus blandit dictum. Nisi porta elementum sed diam eleifend pellentesque. Quis aenean quam.
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