Cell line Development
Viral reduction steps and clearance studies
Demonstrated expertise with E. coli and Mammalian expression platform.
Single-cell clone selection based on high titer and quality attributes.
High throughput screening for clone selection using AMBR 15.
Cell line stability analyses.
Multiple storage location for cell lines
Capability to convert drug substance to stable
Capable of filling all injectable forms
Stability studies on DS and DP as per ICH guidelines