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News|Articles|February 7, 2023
The Center for Breakthrough Medicines Announces Plasmid Manufacturing Service
Author(s)Pharmaceutical Technology Editors
CBM’s plasmid manufacturing offering is designed to provide phase-appropriate plasmids on demand for companies working on cell and gene therapies.
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The Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization, announced the launch of its plasmid manufacturing offering, Precision Plasmids, on Feb. 2, 2023. The service is designed to provide phase-appropriate plasmids on demand for companies working on cell and gene therapies.
According to a company press release, the service uses next-generation sequencing to guarantee reproducibility of vector-based therapies that are manufactured using plasmids. Expected turnaround times are 12 weeks for plasmids from a good manufacturing practice (GMP) master bank, or 17+ weeks for those working from a starting R&D plasmid.
“As a starting material for mRNA [messenger RNA] vaccines and key components for vector-based cell and gene therapies, plasmids are in high demand for the foreseeable future,” said Dana Cipriano, senior-vice-president, Testing and Analytical Services & Plasmids, CBM, in the release. “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.”
The plasmids are offered in three varieties: R&D, Pro, and GMP. The R&D plasmids grade for pre- and early clinical phases, while the Pro grade for toxicology studies, Phase I to II vector production, or as a starting material for mRNA. GMP grade services are expected to launch in April 2023.
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