Closed Manufacturing With Sterile, Single-Use Solutions Using Automated Filling, Producing High-Quality Mammalian Suspension Cell Banks
A fully characterized, homogeneous, cGMP compliant Master Cell Bank (MCB) and Working Cell Bank (WCB) critically impacts the safety, speed and success of the journey from drug development to commercial biologics manufacturing. The MCB and WCB forms the foundation of a product, as all future manufacturing performance is based on the quality of these banks.
Sartorius has extensive experience in single-use technologies, as well as relevant technical and regulatory knowledge to support cell banking. We offer a closed-system cell bank manufacturing platform for mammalian suspension cells that is fully integrated with our Cell Line Development (CLD), biosafety testing, and characterization services. Sartorius can offer manufacturing of >500 vials of MCB in less than 5 months from vial initiation in the cleanroom to final QP release and WCB in less than 3 months.
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.
The 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 utilizing the Sartorius Fill-It. Finally, cell freezing occurs in a validated controlled rate freezer prior to storage in liquid nitrogen vapor phase.
Flexible Manufacturing of Cell Banks
Integrated offering with the latest technology solutions for high-quality cell banking.
- Dedicated cGMP licensed facility
- Standard >500 vials, 12e6 viable cell / cryovial
- Closed and automated single-use process
- Rapid FILL-IT automated fills over 500 vials within 20 minutes
- Validated controlled-rate freezing
- Process Certified broth qualified for sterility assurance
- Qualified Person (QP) batch release
- Flexibility of transfer to any CMO for product manufacture
The Sartorius integrated cell banking and testing service allows for rapid release of cell banks
- Pilot and Engineering runs – 1 month
- MCB manufacturing testing and release < 5 months
- WCB manufacturing testing and release < 3 months
Specializing in cell bank biosafety testing, Sartorius client managers ensure a seamless transition from manufacturing to testing of the banks, ensuring rapid completion of the program
- MCB Testing package completion < 10 weeks
- WCB testing package completion in < 6 weeks
- QC testing plans with Ready to Use (RTU) cGMP validated test methods in accordance with ICH Topic 5A (R1)
The Sartorius CHO cell banking platform was developed using multiple clones from the Cellca Cell Line Development (CLD) platform. Seamless transition from CLD to MCB & WCB manufacturing occurs via an integrated service approach. By combining cell banking with CLD services a project can move from plasmid DNA to final released MCB in less than 10 months.
The CHO cell banking platform is suitable for all CHO cell lines. In most cases, the Sartorius robust CHO cell banking platform allows technology transfer of customers’ own cell culture parameters for adoption into the platform without the requirement for engineering or pilot runs.
80% of viral vector product manufacture has HEK293 cells as the producer cell line. Customers’ HEK293 cell line growth parameters may be directly transferred to the manufacturing team for translation into a cell bank manufacturing process.
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 or pilot run prior to cGMP manufacturing.
The standard offering is for high quality cell banks of greater then 500 vials at 12 million cells per vial. It includes complete flexibility to manufacture the product with any CMO partner.