Pre-GMP Facility

For clinical scale cell engineering in a functionally closed system we chose the "CliniMACS Prodigy" device. It offers a platform for GMP-grade cell processing applications enabling fully automated washing, fractionation, cultivation, transduction, electroporation and magnetic seperation of cells in a functionally closed system. 

The platform´s flexibility allows production of cell products including a wide array of genetic engineering under S2 conditions. Further, automation within this device allows harmonization of cell-production processes in case of multicentric production strategies.

Set-up of the GMP-conform manufacturing process includes generation of SOP, selection of GMP-compatible reagents and up-scale of lab protocols. Pre-validation runs are performed in order to establish the manufacturing process, train staff and prepare production approval.  

"MACSQuant Analyzer" offers a GCP-compatible high-throughput platform for flow-cytometry-based quality control. With a range of automated features, this flow cytometer lays the foundation for standardization of analysis and gating procedures. 

• Absolute quantification of cell populations allows dosing of cell products
• Automation allows harmonization and standardization of quality control analyses in case of multicentric production 
• Development of MACSQuant "Express Modes" offers fast and easy quality control analyses

Quality control strategies are set-up and validated in accordance to the requirements of regulatory authorities.

According to regulatory requirements cell products are pre-clinically characterized using established validation processes and infrastructures:

• Specificity
• Purity
• Potency
• Identity

Standardly, stability assays are perfomed in order to determine the shelf-life of the cell products.