Cell Bank Manufacturing for Biopharmaceuticals
High-Quality Mammalian Cell Banks Via Closed, Single-Use Manufacturing and Automated Filling
The Master Cell Bank (MCB) and Working Cell Bank (WCB) form the foundation of a final drug product, as all future manufacturing performance is based on the quality of these banks. A fully characterized, homogeneous, cGMP compliant MCB and WCB critically impact the safety, speed, and success of the journey from drug development to commercial biologics manufacturing.
Through our extensive experience in single-use technologies, technical and regulatory expertise, we offer a closed-system cell bank manufacturing platform for both mammalian suspension cells and adherent cells.
Explore Our Cell Banking Service
Robust, Rapid, Safe Supply of Cell Line
- More than 120 cGMP cell banks manufactured, tested and QP released
- Flexible manufacturing options in shake flask or bioreactor, custom high cell density banking services for intensified seed trains
- 500 vial, 12mio cells per vial cell banks as standard offering for lower cost of goods
- Closed loop, semi-automated process to mitigate risks in manual handling, contamination and shear stress
- Automated vial filling in <20 minutes to reduce toxicity from overexposure to cytoprotectants
- Integrated cell bank characterization services (ICH Q5A) to accelerate QP release of MCB in under 5 months, and WCB in under 3 months
- Dedicated sites for suspension (serum free) and adherent cell bank manufacturing
- Long-term storage of master and working cell banks available
Suspension cells are used in the manufacturing processes of a variety of biologics due to their ability to expand in large-scale cultures within a small footprint. The most common applications include protein and viral vector production with suspension-adapted cell lines for CHO and HEK293 and viral vaccines.
- Our custom cGMP cleanroom facility located in Newhouse, UK is fully dedicated to mammalian cell lines in suspension. Serum-free, animal component-free media are used to produce cell banks for use in protein and viral manufacturing applications. This closed manufacturing system is fully nutrient-broth qualified to provide added process safety and assurance of sterility.
Our standard offering is for high-quality cell banks of over 500 vials at 12 million cells per vial and includes complete flexibility to manufacture the product with any CMO partner. Perfusion process available for manufacture of high-cell density cell banks for intensified processes.
The suspension cell banking process begins with the revival of cells into shake flask culture within an isolator. Expansion of cell culture occurs in closed single-use systems using the Sartorius Mycap® transfer system and using Sartorius Biowelder® and Biosealer® for aseptic fluid transfer. Closed-system serial cell culture expansion is performed in sterile shake flasks or using the Sartorius Biostat RM® until sufficient cells have been cultivated for the banking process. Harvest is completed using custom-designed manifold systems and rapid automated filling. Finally, cell freezing occurs in a validated controlled-rate freezer prior to storage in liquid nitrogen vapor phase.
Our cell banking platform can be seamlessly integrated within our CLD and biosafety testing and characterization services, going from plasmid to released MCB in under 9 months. We can also use your existing RCB and technology transfer of your cell culture parameters for adoption into the platform. From there, we would release the MCB in under 5 months and WCB in under 3 months.
Adherent cell lines are used in a plethora of different processes and modalities, especially within ATMP development. These include cell and gene therapies, secretome production, exosome production, and more.
Our GMP facility in Lyon, France offers a project-centric approach, with flexibility and adaptability to fit the required customer process. Based on a wealth of experience in single-use technologies, we can deliver a Research Cell Bank (RCB) in under 2 months, a fully-characterized MCB in under 6 months and WCB in under 3 months.
The process begins with the revival of cells into flasks in either A/B or A/C clean rooms, depending on the cell bank requirements. Cell culture expansion occurs in closed-systems using the Sartorius Biowelder® and Biosealer® for aseptic fluid transfer. Cell culture expansion is performed in 2-D or 3-D until sufficient cells have been cultivated before being efficiently filled with semi-automated system of up to 1000 vials . Finally, cell freezing occurs in a validated controlled rate freezer prior to storage in liquid nitrogen vapor phase.
Dedicated cell bank manufacturing scientists and quality professionals create custom production processes for your cell bank. These professionals demonstrate the critical process parameters and quality attributes in a pilot or engineering run prior to cGMP manufacturing.
