Genesis Vector Manufacturing SolutionsTM

Reimagining gene therapy manufacturing with integrated, end-to-end solutions to simplify supply chains and reduce time-to-market. 

CBM’s vector manufacturing capabilities cut time to GMP drug product by more than half. In-house capabilities include: plasmid manufacturing, first-time right (FTR) process development, high throughput vector manufacturing of drug substance and drug product, analytical and testing, regulatory, supply chain, and R&D services all at a single source.  

 

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Integrated, end-to-end development, manufacturing, and testing solutions for vector-based therapies

CBM_Genesis_QBD_icon First-time Right Process Development
CBM_Genesis_PM_icon Precision Plasmid Manufacturing
CBM_Genesis_VV_icon High Throughput GMP Manufacturing
CBM_Genesis_AAT_icon Integrated Analytical & Testing Capabilities
CBM_Genesis_ES_icon Enabling Regulatory & Research Services
CBM_GenesisLP_ImageAsset-2

Process Development

Ensure first-time right manufacturing and 2-month faster tech transfer to GMP

When a process scales, variability can affect a delicate vector. Process development efforts including characterization and stability studies are critical for successful manufacturing at later clinical and commercial scale. CBM’s first-time right process development is underpinned by a Pilot Plant that can manufacture in GMP conditions with flexibility in scale and scheduling. Tech transfers are facilitated by having GMP teams train, develop documentation, and begin the bill of material for GMP manufacturing.

 

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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 PlasmidsTM 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.

 

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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.

 

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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.

 

CBM_GenesisLP_ImageAsset-2

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.

Integrated, end-to-end development, manufacturing, and testing solutions for vector-based therapies

CBM_Genesis_QBD_icon

First-time Right Process Development

Process Development

Ensure first-time right manufacturing and 2-month faster tech transfer to GMP

When a process scales, variability can affect a delicate vector. Process development efforts including characterization and stability studies are critical for successful manufacturing at later clinical and commercial scale. CBM’s first-time right process development is underpinned by a Pilot Plant that can manufacture in GMP conditions with flexibility in scale and scheduling. Tech transfers are facilitated by having GMP teams train, develop documentation, and begin the bill of material for GMP manufacturing.

 

CBM_Genesis_PM_icon

Precision Plasmid Manufacturing

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 PlasmidsTM 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.

 

CBM_Genesis_VV_icon

High Throughput GMP Manufacturing

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.

 

CBM_Genesis_AAT_icon

Integrated Analytical & Testing Capabilities

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.

 

CBM_Genesis_ES_icon

Enabling Regulatory & Research Services

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.

CBM provides the partnership, environment, and expertise for creating your breakthrough medicine.

Learn More About Each of Our Capabilities:

ProcessDev_Icon

Process Development

Testing_Icon

Analytical Development and Testing

Plasmid_Icon

Plasmid DNA Manufacturing

ViralVector_Icon

Viral Vector Manufacturing

CellTherapy_Icon

Cell Therapy Manufacturing

CBM

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Manufacture. Breakthrough.

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