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 says it 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. Both Precision Plasmids R&D and Pro are available now, while Precision Plasmids GMP grade will be available in April 2023.

The quality of CBM’s Precision Plasmids is confirmed by Next Generation Sequencing (NGS) to guarantee the reproducibility of vector-based therapies that are manufactured using plasmids. Precision Plasmids can be used as standalone starting material or within CBM’s integrated Genesis Vector Manufacturing Solution. According to the company, clients can expect turnaround times (TATs) of 12 weeks from a GMP master cell bank or 17+ weeks from a starting R&D plasmid.

Precision Plasmids Pro are manufactured using a platform process and GMP platform analytics for preclinical and early-phase clinical trials. CBM’s 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.

“As a starting material for mRNA vaccines and key components for vector-based cell and gene therapies, plasmids are in high demand for the foreseeable future,” said Dana Cipriano, CBM’s senior vice president of testing and analytical services and plasmids. “CBM’s Precision Plasmids solve the capacity challenge by bringing a platform process, multiple scales, and segregated suites to meet any clinical and commercial production needs on demand.”