Cell Bank Manufacturing

Fully characterized, well-documented, homogeneous master cell banks (MCB) and working cell banks (WCB) are critical attributes to mitigate risk and ensure safety and product quality of any biological product. Utilising BioOutsource’s CRO expertise, our highly experienced team have expanded our service offering to include cell bank manufacturing.

In addition, we also offer comprehensive biosafety testing services, including cell bank characterization and genetic stability assessments of the final producer cell lines.

BioOutsource is able to offer a cGMP compliant cell banking service. The traditional cell bank preparation culture process begins by thawing a cryopreserved vial of a research cell bank into shake flask cultures followed by successive, time-consuming, expansion steps to achieve the desired cell number prior to filling. These manipulations increase the risk of potential contamination of the cell bank production. BioOutsource and Sartorius Stedim Biotech have combined their expertise to develop an industry leading closed-system, single-use and fully cGMP compliant cell banking manufacturing process with comprehensive PAT options available.

Key points to note

  • Closed, single-use manufacturing system with in-line monitoring and control
  • Up to 500 vial cell banks at 1-3×107 cells per vial
  • Automatic vial filling system and controlled rate cryopreservation
  • Animal product free production

Inoculating initial seed stock directly into a Biostat® Flexsafe® RM bioreactor and monitoring and controlling cell expansion allow sufficient cells to be prepared in a completely closed system thus eliminating potential risks. Master cell banks can be prepared at up to 500 vials allowing ample opportunity to produce early clinical grade material prior to later WCB manufacture.

Vial filling into cryo vials is then completed using Sartorius’ Fill-it automated benchtop filling system. This operation is conducted within an aseptic isolator thus eliminating the need for laborious manual fill and further mitigating the risk of potential contaminants. Typical fill volumes of 1ml and 1-3×107 cells.

The vialed cells are then frozen at a controlled rate to minimize freeze-related trauma and stored prior to release in vapour phase of liquid nitrogen.

Visit the Sartorius Stedim Biotech website to see the full range of equipment and technologies available for manufacturing.

Contact our experts to discuss your cell bank manufacturing and cell bank characterization requirements.

 

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