Feb 02, 2023, 09:04 ET
Superior quality Precision Plasmids™ expedite clinical trial timelines with no wait time to start manufacturing custom plasmids
KING OF PRUSSIA, Pa., Feb. 2, 2023 /PRNewswire/ -- 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. Both Precision Plasmids™ R&D and Pro are available now, while Precision Plasmids™ GMP grade will be available in April 2023.
CBM Precision Plasmids™ 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 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.
"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 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."
Visit https://breakthroughmedicines.com/plasmid-dna-manufacturing/ to learn more.
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.
Center for Breakthrough Medicines
SOURCE Center for Breakthrough Medicines
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