质粒 DNA CDMO 服务

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.

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.

Fully single-use upstream processing (USP) available for GMP, HQ, and RG plasmids, with shake flask or bioreactor options to support production requirements.

A scalable, single-use, alkaline lysis process to support retention of plasmid quality and efficient removal of host cell contaminants.

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.

Qualified fill finish options at a range of volumes to suit your application.

Leveraging our integrated biologics testing powerhouse, we offer 100% in-house testing panels for cell banks through to final material release.

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.

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.

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.