My Question--.docx - Part A Bioreactor Scale up QuantyBio Corporation is developing a monoclonal antibody and they need your help They need to make

My Question--.docx - Part A Bioreactor Scale up QuantyBio...

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Part A: Bioreactor Scale upQuantyBio Corporation is developing a monoclonal antibody and they need your help. They need to make preclinical (pK and toxicology) and Clinical (Phase I) mate-rial for their clinical program.The company has developed a cell line that produces about 600 mg/L in a batch cul-ture in 7 days.Cell density: Start at 0.5 MM/mL, max 15 MM/mL, end viability =40%Specific productivity of these cells are at qp=35 pg/cell/dayThe cells have a specific oxygen consumption of qO2=0.22 uM/MM-hrA research cell bank (RCB) is made and kept frozen in LN2 freezer (a total of 20 vialsof RCB)1.They would like to develop a fed-batch process and optimize it. The tar-geted process will look like this:a. Starting cell density: 0.5 Million cells/mLb. Titer =2 g/Lc. Culture duration= 14 daysd. Viability at the end of the culture >50%e. Chemically defined medium and feedsf. 3 step purification step,g. Overall yield >50% (bioreactor to final vial)h. Final formulation: 25 mg/mLi.
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