Product/Service

Viral Vector Manufacturing

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The Center for Breakthrough Medicines (CBM) operates the world’s largest single-site advanced therapies facility, with over twenty suites focused on scalable production of viral vectors, including Adeno associated virus (AAV), Lentivirus (LVV), HSV, Adenovirus, and other viruses.

This state-of-the-art site is run by a world-class team, including some of the most experienced talent in vector manufacturing. Our solutions efficiently and consistently deliver high yields without compromising quality, accelerating the availability of new therapies to patients who need them.

  • Starting material, drug substance, drug product, and custom sterile components and buffers.
  • Access to the AAV platform from the lab that pioneered the first gene therapy.
  • Partner in Plant model that offers the flexibility for you to work alongside our subject matter experts in our Process Development Labs and to be present during GMP operations in our manufacturing suites.
  • 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.
  • Support for client programs throughout the entire product lifecycle from development to commercialization in both adherent and suspension batches up to 2,000 L.
  • Dedicated Scientific Program Leader and Project Manager to oversee every client project.
  • Integrated Process Development drives flawless clinical and commercial GMP manufacturing.
  • Option of a dedicated custom cGMP suite under a long-term service agreement.
  • BLA-ready suites to support clinical through commercial manufacturing.

Facility Design

Starting Materials

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. 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

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