GI Partners Acquires CDMO and Cell Solutions
As Rose BioSolutions, the established CDMO and Cell Solutions businesses continue to support the biotechnology ecosystem with cell sourcing capabilities and CDMO services to accelerate your advanced therapy from development to delivery.
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Linearized Plasmid Starting Materials for Your mRNA Therapy
Plasmid DNA critical starting materials play a foundational role for a range of common advanced therapy modalities. In the case of mRNA, plasmid DNA constructs carrying the gene of interest must be linearized using a restriction enzyme to deliver a template for in vitro transcription (IVT). To produce functional mRNA, production of the initial plasmid construct, subsequent plasmid linearization by restriction digest, purification, and release testing are of critical importance to deliver intact template DNA for efficient IVT.
Available stand-alone or as a modular add-on to phase-appropriate plasmid production, our plasmid linearization service utilizes a robust plug-and-play screening toolbox to manage long polyA sequences that are prone to truncation. Fully compatible with a range of commonly used restriction enzymes and construct designs, this negates the requirement for extensive development and optimization, supporting reduced development and manufacturing timelines for your linearized plasmid.
Looking for reliable plasmid linearization services to support onward mRNA manufacturing?
Plasmid Linearization to Support Your Program from Concept to Cure
Available in GMP, HQ and research grade, supercoiled and linearized plasmid production can be scaled from mg to multi-gram, with unparalleled quality control and technical support to safeguard critical starting materials supply with the end-product in mind.
The linearization module add-on leverages all the advantages of the proven eXpDNA™ plasmid production platform: fit-for-purpose custom plasmid services focused on standardization, efficiency and product quality. Utilizing single-use technologies and 100% in-house testing, our team can expedite development and production timelines to as little as five weeks for High Quality (HQ) and ten weeks for GMP grade, to support your program timelines.
Manufacturing QC for Plasmid Critical Starting Materials
In today's evolving advanced therapies ecosystem, plasmid DNA retains its common role as a critical starting material for a range of advanced therapeutic modalities, laying the foundations for mRNA and CGT production.
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Advantages of Linearized Plasmid Service
- Host strain and fermentation screening to support polyA stability and deliver high yield
- Delivery of mg to multi-gram quantities of linearized plasmid and a range of fill options
Typical Testing Specifications for HQ and GMP Linearized Plasmid
| Test | Method | HQ Acceptance Criteria | GMP Acceptance Criteria |
|---|---|---|---|
| Appearance | Visual Inspection | Clear, colorless solution free from visible particulate matter | Clear, colorless solution free from visible particulate matter |
| pH | USP <791>, Ph. Eur. 2.2.3 | 8.0 ± 0.5 | 8.0 ± 0.5 |
| Identity | Restriction digest | Plasmid identity confirmed | Plasmid identity confirmed |
| Quantity | Total Nucleic Acid by Absorbance Spectroscopy | 1.0±0.1mg/mL | 1.0±0.1mg/mL |
| Purity | OD260:280 | 1.8-2.0 | 1.8-2.0 |
| Purity | Agarose Gel Electrophoresis | ≥90% linearized | ≥90% linearized |
| Endotoxin | USP <85>, Ph. Eur. 2.6.14 | ≤10 EU/mg | ≤10 EU/mg |
| Residual genomic DNA | qPCR | ≤5% | ≤2% |
| Residual host cell protein | ELISA | ≤2% | ≤1% |
| Residual host cell RNA | RP-HPLC | ≤5% | ≤1% |
| Residual kanamycin | Colorimetric analysis | ≤5 ppm | ≤5 ppm |
| Bioburden | USP <61>, Ph. Eur. 2.6.12, 2.6.13 | TAMC - <1 cfu/10mL TYMC - <1 cfu/10mL | TAMC - <1 cfu/10mL TYMC - <1 cfu/10mL |
| Sterility | USP <1071> | No growth | No growth |
| Identity | Sequencing | Identical to plasmid DNA reference sequence (polyA tail ≥xxxbp) | Identical to plasmid DNA reference sequence (polyA tail ≥xxxbp) |
Ready to discuss your plasmid linearization needs?