Viral Vector ManufacturingCONNECT WITH AN EXPERT
Viral vector CDMO offering manufacturing services from concept to commercialization.
Viral Vector CDMO Services
The Center for Breakthrough Medicines (CBM) offers a purpose-built manufacturing facility, with over twenty suites focused on scalable production of viral vectors, including Adeno-associated virus (AAV), Lentivirus (LV), HSV, Adenovirus, and other vectors.
Our end-to-end vector manufacturing capabilities consistently deliver high yields and higher throughput without compromising quality to accelerate the availability of new therapies to patients who need them. Our solutions include:
- Comprehensive manufacturing including starting material, drug substance, drug product, and custom sterile components and buffers significantly simplifying supply chain
- Integrated Process Development to drives flawless clinical and commercial GMP manufacturing.
- Flexible Platforms/process options to fit the need: Clients have access to the AAV Vector platform from the lab that pioneered the first AAV gene therapy or our process development team can work to efficiently transfer in client processes or build custom processes. Support for client programs throughout the entire product lifecycle from development to commercialization in both adherent and suspension batches up to 2,000 L.
- In-house Manufacturing and release testing of both raw materials and product destined for clinical trials and commercial supply are performed under cGMP right across the hall from manufacturing.
Partner with Experts
- Transparency and Collaboration: Partner in Plant model offers clients the flexibility to work alongside our subject matter experts during process development and to be present during GMP operations. Collaboration and Focus: Dedicated Scientific Program Leader and Project Manager to oversee every client project. Option of a dedicated custom cGMP suite under a long-term service agreement.
- Proven Experts: 85+ years of collective experience in biotech and manufacturing and 10,000+ batches produced in the last 20 years
- Differentiated Capabilities and Capacity: 20+ BLA-ready (designs reviewed by the FDA/CBER and found acceptable) suites to support clinical through commercial manufacturing.
- Onsite Fill/Finish grants greater control of secondary and tertiary packaging to reduce contamination risk, reduces product risk from multiple shipments and simplifies supply chains and the path of clinic. High-performing fill lines and in-process testing reduces risk of product loss
Viral Vector Facility Design
Viral Vector Starting Material
Starting materials are the foundation for long-term quality of your products and therapies; CBM provides in-house solutions to simplify and streamline our clients' supply chains – our cell line in development has interim data showing savings 25% of COGS. As with all our services, everything is integrated on a single-site, promoting efficiency and risk mitigation.
- Cell banks
- Viral stocks and viral banks
- Reference standards
Explore our Viral Vector Capabilities
Adherent process for all viral vectors
- Flatware up to 50 x HS batches
- Large Grade B and C suites
- Fixed-bed bioreactors
Suspension process for all viral vectors
- 50 L – 2,000 L capabilities
- Diverse technology vendors to de-risk consumable supply chain
Harvest and concentration/diafiltration
- Depth filtration
- Tangential Flow Filtration
- Size exclusion
- Ion exchange
- Hydrophobic interaction
Drug Product Capabilities
- Semi-automated filler, aseptic in design
- Targeting product hold up <5mL, approximately 3,000 units (2R) per batch
- Flexible single needle with integrated IPC and closure
- Range of 0.1-50mL in glass or Crystal Zenith vials
- Support up to 24,000 vials
- Same aseptic and single-use philosophy as a higher throughput aseptic Isolator
- 100% IPC and inline CCIT
- Limited product loss
- Glass and CZ/Polymer capabilities
Visual Inspection and Packaging
- Filled vials go through 100% inspection by qualified operators
- GMP labeling and packaging
Reduced Time out of Refrigeration
- Manufacture of plasmid DNA as a critical starting material for the transfection process required for viral vectors
- cGMP drug product formulation and fill/finish services
Contact us to discuss how CBM’s integrated capabilities can support your program
Viral Vector Manufacturing
CBM’s viral vector capabilities efficiently and consistently delivers high yields in AAV, Lentivirus, HSV and Adenovirus vectors, accelerating the development of new therapies.
Cell Therapy Manufacturing
CBM has one of cell therapy’s most experienced teams and the largest single site facility in the industry. There is no greater centralization of expertise.
Our Experienced Team
Our team brings a wealth of experience from biopharma and advanced therapy CDMOs, ensuring that there is no safer place for your product.