definiens: means results demonstrating ( a ) the ability to grow cells expressing an E Compound in suspension culture [ in spinner flasks ] for [ ninety ( 90 ) days ], achieve a [ stable productivity ] throughout the period, and maintain an [ overall cell viability above ninety percent ( 90 % ) ], and ( b ) in [ three ( 3 ) consistency runs ] using [ perfusion ] culture the ability to reach a [ maximum cell density of at least 3xl06 cells / ml within eight ( 8) days ] of inoculation followed by [ twenty ( 20 ) days of stable production ] of an E Compound in a bioreactor working volume of at least [ five ( 5 ) liters ], with [ cell viability of at 11 02660.2A * * * * Confidential Treatment Requested least eighty percent ( 80 % ) ], and with [ superimposable growtb curves, Product productivity curves and cell viability curves between the consistency runs ] and ( c ) the ability to purify an E Compound from the [ three ( 3 ) perfusion ] cultures with a [ final recovery ] yield of [ two and one - half ( 2.5 ) ] mg / L [ perfusion ] reactor harvest with a consistent Product quality in terms of [ gamma carboxylation, glycosylation and isoforms ], and ( d ) complete written documentation of Standard Operating Procedures for the [ perfusion ] culture process and the purification process