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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Safeguard Your Starting Materials with Plasmid DNA CDMO Solutions
To cater to the diverse demands of cell and gene therapy development, we provide a comprehensive suite of plasmid DNA manufacturing services to support preclinical research studies through to clinical development and commercial supply. You can provide an existing plasmid for production or rely on us to generate a custom plasmid tailored to your precise requirements. Additionally, our team offers end-to-end scientific support, encompassing both upstream and downstream process development for every plasmid DNA production program.
| Plasmid Grade | Plasmid Application | Plasmid Production Environment |
|---|---|---|
| Research Grade (RG) Plasmid DNA | For in vitro R&D and preclinical studies | R&D grade production laboratory |
| High Quality (HQ) Plasmid DNA | For toxicology studies, Phase I-II critical starting materials to support viral vector and mRNA manufacturing | Dedicated, segregated manufacturing suite |
| Good Manufacturing Practice (GMP) Plasmid DNA | For all stages of clinical and commercial supply for viral vector manufacturing and DNA vaccines | Full GMP clean room manufacturing suite |
Quality is the cornerstone of our service offerings, ensuring the highest quality cell banks and final purified plasmid DNA, therefore minimizing risk of cross-contamination. With more than two decades of experience at our plasmid DNA CDMO center of excellence, our team has developed a robust plug-and-play toolbox screening approach for challenging plasmid types, fully single-use processing methods, and established comprehensive testing and release to meet current regulatory requirements.
Ready to discuss an upcoming plasmid DNA manufacturing program?
Universal Plasmid Manufacturing Platform to Streamline the Development Pathway
Focused on standardization, speed and product quality, the eXpDNA™ plasmid production platform supports your program strategy, streamlining development and expediting production timelines to as little as five weeks.
To drive successful outcomes in cell and gene therapy development, we harness advanced filtration techniques, RNAse- and animal-free components, and extensive expertise to ensure your plasmid DNA meets the highest industry standards.
“eXpDNA is at the nucleus of our plasmid production offering. The significant turnaround time reduction for clients leveraging the platform, combined with Charles River’s established CDMO capabilities and phase-appropriate approach, will help to both accelerate timelines and ensure the highest quality product.”
Andrew Frazer, PhD, Associate Director, Scientific Solutions, Gene Therapy CDMO Services, Charles River
Plasmid DNA Production Process
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Screening and Pre-Production Evaluation
Extensive experience in the assessment and delivery of plasmids containing ITRs, poly-A, LTRs using our plug-and-play screening toolbox to prepare reliable cell banks for onward manufacture. Construct development, host cell-line evaluation and full molecular biology capabilities are available.
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Cell Banking
Production of master and working cell banks (MCB/WCB) in a range of host cell lines. HQ grade cell bank options available to support intermediate grade plasmid manufacture while maintaining a pathway to future GMP supply, when needed.
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Fermentation
Fully single-use upstream processing (USP) available for GMP, HQ, and RG plasmids, with shake flask or bioreactor options to support production requirements.
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Cell Harvesting and Lysis
A scalable, single-use, alkaline lysis process to support retention of plasmid quality and efficient removal of host cell contaminants.
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Two-Step Chromatographic Purification
Using fully single-use pre-packed columns, our two-step chromatography process maintains high supercoiled plasmid and removes residual host cell DNA, RNA, host cell proteins, and endotoxin.
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Aseptic Fill Finish
Qualified fill finish options at a range of volumes to suit your application.
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In-House Analytics
Leveraging our integrated biologics testing powerhouse, we offer 100% in-house testing panels for cell banks through to final material release.
Plasmid DNA from Concept to Cure
Exploring the challenges and considerations throughout CGT development, start with the end in mind and download this resource to inform your critical starting materials strategy.
Access Guidebook
“Our team is proud to be leading a revolution in the treatment of kidney diseases and understands that a key factor to our success is developing a robust and reliable CMC platform. Purespring’s established relationship with Charles River leverages a breadth of contract development and manufacturing experience and expertise.”
Julian Hanak, former Chief Executive Officer, Purespring Therapeutic
From Research to Commercial: Which Plasmid Grade Suits Your Program?
| Plasmid DNA Production Conditions and Options | RG Plasmid | HQ Plasmid | GMP Plasmid |
|---|---|---|---|
| Cloning/Synthesis/Mutagenesis of plasmid (optional) | ✓ | ✓ | ✓ |
| Scale-up and manufacturing of existing plasmid constructs | ✓ | ✓ | ✓ |
| Multiple production scales (shake flask through fermenters) | ✓ | ✓ | ✓ |
| Proven plasmid manufacturing and purification processes for high yield and recovery | ✓ | ✓ | ✓ |
| Standardized manufacturing platform | ✓ | ✓ | |
| Establishment of E. coli master and working cell banks | ✓ | ✓ | |
| Upstream process development (optimization of transformation and culture conditions, strain, etc.) | ✓ | ✓ | |
| Downstream process development (optimization of purification and formulation conditions) | ✓ | ✓ | |
| Full traceability of materials | ✓ | ✓ | |
| Full room changeover prior to each production | ✓ | ✓ | |
| Production in segregated and dedicated space | ✓ | ✓ | |
| Process and change control | ✓ | ✓ | |
| Aseptic fill/finish | ✓ | ✓ | |
| Document support for IND and IMPD filing | ✓ | ✓ | |
| Master Batch Records (client-specific) | ✓ | ✓ | |
| Stability studies (optional) | ✓ | ✓ | |
| Product release tests | ✓ | ✓ | |
| QA Oversight for production | ✓ | ✓ | |
| Plasmid manufacturing in CGMP suite with graded air | ✓ | ||
| Complete environmental monitoring throughout production process | ✓ |
Frequently Asked Questions (FAQs) About Plasmid DNA Manufacturing Services
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What materials are used for plasmid production?
Charles River’s eXpDNA™ platform utilizes fully single-use process materials throughout, providing operational benefits on timelines and suite occupancy, effectively ruling out the possibility of plasmid cross-contamination. In addition, all process specific raw materials are sourced under vendor assurance procedures and are free from animal origin.
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What are the differences between research grade, HQ, and GMP Plasmids?
Research Grade (RG) plasmids are suitable for in vitro R&D and preclinical studies, offering a high level of quality for experimental purposes.
High Quality (HQ) plasmids offer a phase-appropriate, intermediate grade solution, designed for toxicology studies and early-phase clinical trials, our HQ plasmid manufacturing process adopts the principles of GMP according to EMA guidance for plasmid starting materials.
GMP, or Good Manufacturing Practice, grade plasmids adhere to the strictest regulatory standards, making them suitable for late-phase clinical trials and commercial therapeutic applications. They undergo rigorous quality assurance processes to meet all regulatory requirements.
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How do off-the-shelf viral vector packaging plasmids differ from custom-made plasmids?
Our off-the-shelf viral vector packaging plasmids are pre-manufactured and ready for immediate use. Plasmids are designed based on commonly used sequences and configurations, making them suitable for a wide range of applications.
Custom-made plasmids, on the other hand, are designed and manufactured to a client's specifications. This allows for greater flexibility in terms of sequence, configuration, and other unique requirements, ensuring a perfect fit for the intended application. Both options maintain high-quality standards, but the choice between them often depends on the project's specific needs and timelines.
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Explore our Plasmid DNA CDMO Facility
Integrated within a concept to cure CGT portfolio, the team leverages an established plasmid production platform to produce reliable, fit-for-purpose critical starting materials.
Explore the Facility