Industry News: Center for Breakthrough Medicines Launches Precision Plasmids™ Manufacturing to Accelerate Advanced Therapies into the Clinic

Superior quality Precision Plasmids™ expedite clinical trial timelines with no wait time to start manufacturing custom plasmids

Biostat CultiBag STR
Biostat CultiBag STR

The Center for Breakthrough Medicines (CBM), a contract development, and manufacturing organization (CDMO), has launched its plasmid manufacturing offering, Precision Plasmids™ to provide phase-appropriate plasmid on-demand for any company seeking to accelerate their path to clinic for cell and gene therapies. CBM offers NO WAIT TIMES for Precision Plasmids™ R&D grade for pre- and early clinical phases, and Precision Plasmids™ Pro grade for toxicology studies, Ph1-2 vector production, or as a starting material for mRNA. 

CBM Precision Plasmids™ are of the highest quality, to guarantee the reproducibility of vector-based therapies that are manufactured using plasmids. Whether standalone starting material or within CBM’s integrated Genesis Vector Manufacturing Solution™, cell and gene therapy companies can start development and manufacturing today. Underpinned by cell banking, manufacturing, and testing at a single site, clients can expect turnaround times (TATs) of 12 weeks from a GMP master cell bank or 17+ weeks from a starting R&D plasmid.

Recognizing the global need for plasmid manufacturing capacity, challenges with securing the quality needed, and long wait times at competitor facilities, CBM will provide superior plasmids on-demand, at scale, and for every phase of development. Across a range of starting plasmids, the Precision Plasmids™ process focuses on delivering key quality attributes:

• 85%+ DNA Homogeneity (Supercoiled)

• ABS 260/280 between 1.8 and 2.0

• Deep plasmid resequencing via NGS to detect variants down to 5% in addition to Sanger sequencing

Precision Plasmids™ Pro are manufactured using a proven platform process and GMP platform analytics for preclinical and early-phase clinical trials. CBM’s robust platform was developed to accommodate multiple plasmid sizes and complexities to ensure robust manufacturing output.  In addition, the Precision Plasmids™ Pro product utilizes CBM’s complete Quality Management System (QMS), including equipment validation and maintenance, deviation management, corrective/preventative action (CAPA) management, and 100% quality review prior to batch release.

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Source: Reprint courtesy of PRNewswire; Photo courtesy of Biostat CultiBag STR

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