Product/Service

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Integrated manufacturing of GMP cell and viral banks, and supporting characterization and release testing.

Services focused on ensuring the safety and longevity of critical biological starting materials

Cell and viral banks are a vital component for the manufacture of many cell and gene therapy products. It is critically important to ensure uniformity of the population, maintenance of cell integrity, and availability of sufficient material to support the entire lifecycle of the project.

Center for Breakthrough Medicines (CBM) offers clients the capability to manufacture GMP Master Cell Banks (MCB), Working Cell Banks (WCB), Master Viral Banks (MVB), and Working Viral Banks (WVB) as either a stand-alone service or in support of manufacturing campaigns. This production is fully integrated with characterization, release testing and stability studies at our single site, allowing for streamlined and accelerated availability of these critical starting materials.

Mammalian GMP Cell Banking

GMP Viral Banks

GMP Microbial Cell Banking for Plasmid DNA

Double layer MCB and WCB for cell therapy

At CBM, we offer the industry-standard double layer cell banking system, comprising a Master Cell Bank (MCB) and production of a Working Cell Bank (WCB), which ensures customers have access to an inexhaustible supply of consistent cells. The cell banks are characterized and tested for contaminants in line with guidelines and subject to all best practices for handling, testing and storage – eliminating the number of times the cell line is handled, supporting your manufacturing process and regulatory submissions.

Master Viral Banks and Working Viral Banks

CBM also offers GMP production of Master Viral Banks (MVB) and Working Viral Banks (WVB) in support of viral-based products or production systems. This can be offered as a stand-alone service or in support of manufacturing campaigns at CBM. Our expansive campus allows for segregated buildings dedicated to virus manufacturing to ensure no cross-contamination. Colocation of viral cell banking services with the broader manufacturing services and the necessary testing allows for streamlined execution of manufacturing campaigns with coordinated timelines for the readiness of these critical starting materials.

The Center for Breakthrough Medicines