Overall yield >50% (bioreactor to final vial) h. Final formulation: 25 mg/mL i. Fill volume: 2 ml in a 3ml vial (liquid formulation) 8. The size of the preclinical and clinical trials are as follow: a. Preclinical: 300 vials are needed from a GLP lab b. Clinical: 5000 vials are needed from a GMP facility 1. Preclinical material: a. Calculate the amount of material (in grams) to be made in the bioreactor based on preclinical trial needs b. Calculate the size of the bioreactor (in Liters) to be used Based on answer (4b) above 1. Calculate the dimensions of the bioreactor, Diameter, Height, Impeller diameter, Cross sectional area (A), etc. In terms of impeller, the bioreactor for preclinical study will have a pitched blade impeller
operated at 200 rpm 2. What are the Oxygen Transfer Rate (OTR) Requirements of the cells at a maximum cell density of 20 MM/mL? 3. What is the kla requirement is pure O2 is used in the gas and the DO is maintained at 50% air saturation 4. The bioreactor for preclinical study will have a microsparger and it can maintain DO at 20 MM/mL densities with a gas flow rate of 1 Liter per minute. What is the vvm and what is the gas superficial velocity (u=Qg/A) 5. Using kla=a(RPM)^b(vvm)^c correlation with b=0.35 and c=0.75, what is the value of a for kla correlation? 6.