Problem set #2_2020_Fall.docx - Problem Set 2 BIOT 5631 \u201cCell Culture Process for Recombinant Protein Production\u201d Part A Bioreactor Design(3 points

Problem set #2_2020_Fall.docx - Problem Set 2 BIOT 5631...

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Problem Set # 2 BIOT 5631 “Cell Culture Process for Recombinant Protein Production” Part A: Bioreactor Design (3 points) 1.NeuBio Corporation is developing a monoclonal antibody and they need your help. They need to make preclinical (pK and toxicology) and Clinical (Phase I) material for their clinical program.2.The company has developed a cell line that produces about 800 mg/L in a batch culture in 7 days. 3.Cell density: Start at 0.5 MM/mL, max 15 MM/mL, end viability =50%4.Specific productivity of these cells is at qp=25 pg/cell/day5.The cells have a specific oxygen consumption of qO2=0.20 uM/MM-hr6.A research cell bank (RCB) is made and kept frozen in LN2 freezer (a total of 20 vials of RCB)7.They would like to develop a fed-batch process and optimize it. The targeted process will look like this:a.Starting cell density: 0.5 Million cells/mLb.Titer =3 g/Lc.Culture duration= 14 daysd.Viability at the end of the culture >70%e.Chemically defined medium and feedsf.3 step purification process, g.Overall yield >50% (bioreactor to final vial)h.Final formulation: 50 mg/mLi.Fill volume: 2 ml in a 3ml vial (liquid formulation)8.The size of the preclinical and clinical trials is as follow:a.Preclinical: 200 vials are needed from a GLP labb.Clinical: 5000 vials are needed from a GMP facilityAs experienced process development personnel, you are to analyze the situation and summarize your findings to your manager.1.Comment on whether these cells have good specific productivity or not2.
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