Superior quality Precision Plasmids™ expedite clinical trial timelines with no wait time to start manufacturing custom plasmids
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.
To learn more visit https://breakthroughmedicines.com/plasmid-dna-manufacturing/
Source: Reprint courtesy of PRNewswire; Photo courtesy of Biostat CultiBag STR