Center for Breakthrough Medicines Launches Precision Plasmids™ Manufacturing to Accelerate Advanced Therapies into the Clinic
Superior quality Precision PlasmidsTM expedite clinical trial timelines with no wait time to start manufacturing custom plasmids
King of Prussia, PA — February 2, 2023 — The Center for Breakthrough Medicines (CBM), a contract development, and manufacturing organization (CDMO), has launched its plasmid manufacturing offering, Precision PlasmidsTM 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 PlasmidsTM R&D grade for pre- and early clinical phases, and Precision PlasmidsTM Pro grade for toxicology studies, Ph1-2 vector production, or as a starting material for mRNA. Both Precision PlasmidsTM R&D and Pro are available now, while Precision PlasmidsTM GMP grade will be available in April 2023.
CBM Precision PlasmidsTM are of the highest quality, confirmed by Next Generation Sequencing (NGS) 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 SolutionTM, 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 PlasmidsTM 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 PlasmidsTM 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 PlasmidsTM 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 SVP of Testing and Analytical Services & Plasmids. “CBM’s Precision PlasmidsTM solve the capacity challenge by bringing a platform process, multiple scales, and segregated suites to meet any clinical and commercial production needs on demand.”
Visit https://breakthroughmedicines.com/plasmid-dna-manufacturing/ to learn more.
About The Center for Breakthrough Medicines (CBM)
The Center for Breakthrough Medicines (CBM) is a cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, manufacture and market life-saving therapies and treatments on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, best-in-class pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities.
Purpose-built and patient-driven, CBM was designed from the ground up to be a more-effective CDMO; providing single-source, end-to-end solutions to deliver true partnership and unprecedented value to its customers through teamwork, transparency and speed-to-market dedication.