Precision Plasmid Manufacturing

Seamless supply chain eliminates 12-month waits 

Plasmids are a critical starting material for vector production. As a common bottleneck, ensuring a steady supply is critical to uninterrupted manufacturing. CBM’s Precision Plasmids^TM guarantees quantity and quality (e.g., plasmid supercoiled topology of 80%+, absorbance ratio purity between 1.8 and 2.0) to support later vector yields.

High Throughput GMP Manufacturing

Up to 88% more batches annually per suite with capabilities for a wide array of viral vectors 

Facilities were designed by former regulators to meet both clinical and commercial quality standards. There is no changeover required between clinical and commercial supply, further accelerating speed to market. Modular unit operations in downstream and upstream processes are decoupled to maximize efficiency and continuous manufacturing enabling 2 to 5X more batches per suite annually. The inaugural facility is engineered, built, and outfitted to support adeno-associated virus (AAV), lentivirus, adenovirus, retrovirus, herpes simplex virus, baculovirus, and other novel vectors safely and with the highest regulatory and segregation controls.

Integrated Analytical & Testing Capabilities

On-site capabilities cut testing TAT by 2/3 and reduces sample volumes needed up to 50%

CBM’s Analytical Accelerator™ for Vector Testing Platform speeds time to GMP batch release more than three-fold (from 22 to 6 weeks) with no wait times and a complete package of platform assays across the full spectrum of FDA quality domains located at a single provider. Consolidating providers allows gene therapy developers to ship to a single laboratory, reducing sample volumes needed by up to 50 percent. Beyond platform assays, custom assay development can be performed in half the time (6 months vs. 12) of de novo development using Analytical Accelerator™ methods.

Enabling Regulatory & Research Services

Regulatory intelligence reduces risk and supports submissions. R&D support available for vector design and optimization.

A focus on the rapidly evolving regulatory landscape underpins CBM’s ability to lay a seamless, regulatory pathway for our clients’ gene therapy programs. Services include INTERACT, pre-IND and pre-BLA meetings, end-of-phase meetings, Breakthrough Therapy designation / PRIME meetings, Type A,B,C meetings, and scientific and data-based strategic planning and guidance.

To avoid future comparability studies, CBM offers optional R&D services to engineer better vectors with a comprehensive capsid review and selection process. Cell line development of both adherent and suspension cells, process and analytical assay improvements, and Design of Experiments (DoE) can deliver a custom, proprietary platform for your gene therapy.