The Center for Breakthrough Medicines (CBM) offers a purpose-built manufacturing facility, with suites focused on scalable production of viral vectors, including Adeno-associated virus (AAV), Lentivirus (LV), HSV, Adenovirus, other vectors, as well as non-viral modalities.
Viral Vector Manufacturing CDMO Services
We provide custom development and viral vector manufacturing services as well as off-the-shelf products. Our viral vector manufacturing capabilities consistently deliver high yields and higher throughput without compromising quality.
Gene Therapy Viral Vector CDMO Services
Plasmid & Starting Material
- • 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 to support later vector yields.
- • Cell line, cell banks, viral stocks and banks, and reference standards to simplify and streamline our clients’ supply chains
Vector Starting Material
- • 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 utilizes the same scales and equipment as in GMP with flexibility in scale and scheduling.
- • Available cell line reduces COGS and contributes to a robust and scalable process.
- • Tech transfers are facilitated by having GMP teams train, develop documentation, and begin the bill of material for GMP manufacturing.
- • Digitally enabled systems enables quick transfer of data for more robust development and training opportunities within the PD space.
GMP Manufacturing
- • Flexible and digitally-enabled suite design supports wide variety of vectors including Adeno-associated virus (AAV), Lentivirus (LV), HSV, Adenovirus, other vectors, as well as non-viral modalities.
- • Commercial ready suites with maximum segregation and engineer controls to reduce contamination risk.
- • End-to-end manufacturing including Cell Banks, Viral Banks, Bulk Drug Substance, and Drug Product to simplify supply chains and the path of clinic.
Integrated Testing & Analytical
- • CBM’s Analytical Accelerator™ for Vector Testing 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.
- • Consolidating tests allows shipment to a single laboratory, reducing sample volumes needed by up to 50 percent.
- • Custom assay development can be performed in half the time (6 months vs. 12) of de novo development using Analytical Accelerator™ methods.
- Plasmid & Starting Material
-
Plasmid & Starting Material
- • 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 to support later vector yields.
- • Cell line, cell banks, viral stocks and banks, and reference standards to simplify and streamline our clients’ supply chains
- Vector Process Development
-
Vector Starting Material
- • 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 utilizes the same scales and equipment as in GMP with flexibility in scale and scheduling.
- • Available cell line reduces COGS and contributes to a robust and scalable process.
- • Tech transfers are facilitated by having GMP teams train, develop documentation, and begin the bill of material for GMP manufacturing.
- • Digitally enabled systems enables quick transfer of data for more robust development and training opportunities within the PD space.
- GMP Manufacturing
-
GMP Manufacturing
- • Flexible and digitally-enabled suite design supports wide variety of vectors including Adeno-associated virus (AAV), Lentivirus (LV), HSV, Adenovirus, other vectors, as well as non-viral modalities.
- • Commercial ready suites with maximum segregation and engineer controls to reduce contamination risk.
- • End-to-end manufacturing including Cell Banks, Viral Banks, Bulk Drug Substance, and Drug Product to simplify supply chains and the path of clinic.
- Integrated Testing & Analytical
-
Integrated Testing & Analytical
- • CBM’s Analytical Accelerator™ for Vector Testing 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.
- • Consolidating tests allows shipment to a single laboratory, reducing sample volumes needed by up to 50 percent.
- • Custom assay development can be performed in half the time (6 months vs. 12) of de novo development using Analytical Accelerator™ methods.
CBM Thought Leadership
In the News: Center for Breakthrough Medicines Launches Genesis Vector Manufacturing Solutions™
CBM Expertise
With facilities designed by former regulators to meet clinical and commercial quality standards, each suite supports both clinical and commercial supply to accelerate speed to market upon regulatory approval. We have the experience and dedication to quality required to scale up your viral vector gene therapy project into a patient-ready product. Our end-to-end vector manufacturing capabilities consistently deliver high yields and higher throughput without compromising quality.
Looking for support for your upcoming gene therapy manufacturing program?
New Video: In the Lab
CBM’s vector manufacturing 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. Engineering controls to promote and ensure segregation and contamination management with custom buffers and component prep areas.