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Viral Vector Manufacturing

CONNECT WITH AN EXPERT

Viral vector CDMO offering manufacturing services from concept to commercialization.

Viral vector manufacturing services worker using a touchscreen on machinery at center for breakthrough medicine’s CDMO facility

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:

End-to-end Solutions

  • 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
  • Regulatory Read: 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

Multi-product facility designed to meet clinical and commercial requirements
Engineering controls to promote and ensure segregation and contamination management
High throughput suite designed to support 15-30 batches per year and safeguard capacity
Custom buffers and component prep areas
Multiple warehouse locations

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
Image of equipment used in CBM's viral vector production, manufacturing and development facility in King of Prussia, Pennsylvania

Explore our Viral Vector Capabilities

Upstream 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

Downstream Capabilities

CBM uses advanced filtration and purification technologies for all DSP.

Harvest and concentration/diafiltration

  • Depth filtration
  • UF/DF
  • Tangential Flow Filtration

Chromatography

  • Affinity
  • Size exclusion
  • Ion exchange
  • Hydrophobic interaction

Large-volume ultracentrifugation

Sterile filtration

Drug Product Capabilities

Semi-Automated Filling

  • 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

Automated Isolators

  • 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
  • 0.1-50ml
  • 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

Other Capabilities

Plasmid DNA

  • Manufacture of plasmid DNA as a critical starting material for the transfection process required for viral vectors

Fill-Finish

  • cGMP drug product formulation and fill/finish services