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Scale Up

The document discusses three stages for scaling up a manufacturing process from the laboratory to commercial scale: bench scale, pilot scale, and plant scale. It explains that certain parameters like geometry, agitation, and gassing cannot all be kept constant during scale up because they scale by different values. Maintaining the proper scale up factors and parameters is important to ensure adequate mixing, oxygen supply, and avoid damaging shear forces as the process increases in size. Overall, scaling up is challenging because the parameters influence each other, so technicians must determine the critical parameters and find a balance between scaling the remaining ones.

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Amrie Iam
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145 views7 pages

Scale Up

The document discusses three stages for scaling up a manufacturing process from the laboratory to commercial scale: bench scale, pilot scale, and plant scale. It explains that certain parameters like geometry, agitation, and gassing cannot all be kept constant during scale up because they scale by different values. Maintaining the proper scale up factors and parameters is important to ensure adequate mixing, oxygen supply, and avoid damaging shear forces as the process increases in size. Overall, scaling up is challenging because the parameters influence each other, so technicians must determine the critical parameters and find a balance between scaling the remaining ones.

Uploaded by

Amrie Iam
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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To take a manufacturing process from the laboratory scale to a desired large scale at which it is commercially feasible.

3 Stages
Bench Scale ( 2 20 L) Pilot Scale (100 500 L) Plant Scale (500 20,000 L)

Geometry
Height to Diameter Ratio is held constant
Called aspect ratio

Agitation-based parameters
Mixing time Power input per Volume (P/V) Tip Speed

Gassing-based parameters

NOTE: Cannot keep all parameters constant during scale up because they scale by different values

Vessel Volumes per Minute (VVM) Superficial Gas Velocity (Vs)

Parameter

Definition

Scale-Up Factor
N2=N1(D1/D2)1/4

Why is this Important?

Mixing Time

Amount of time it takes the bioreactor to create a homogeneous environment

N2 agitation speed in scale-up N1 agitation speed in scaledown D1 impeller diameter of scale down D2 impeller diameter of scaleup

Want to ensure that the materials are well-mixed in a timely manner

Power Input per Volume (P/V)

Amount of power transferred to a volume of cell culture through the agitator shaft and impellers

P/V N3/D2
P- power supplied V- Volume of Bioreactor N- Agitation Speed D- Impeller Diameter

Mammalian cells cannot handle a lot of power introduced into the culture media as it can cause small eddies that will shear the fragile cell membranes High shear rates can cause the cell membrane to tear and the cells to die. If scale-up based on constant tip speed is attempted, P/V and mixing time will decrease

Tip Speed

Related to the shear rate produced from the impellers moving through the cell culture media

N2 agitation speed in scale-up N1 agitation speed in scaledown D1 impeller diameter of scale down D2 impeller diameter of scaleup

N2=N1(D1/D2)

Parameter

Definition
means the volume of gas flow (usually measured in slpm, standard liters per minute) per bioreactor volume per minute.

Scale-Up Factor

Why is this Important?


necessary to ensure that enough oxygen will be supplied to the cells

Vessel Volumes per Minute (VVM) Superficial Gas Velocity (Vs)

Volume of Gas Flow/time

volume of gas per crosssectional area of the vessel.

Vs- superficial gas velocity Qgas- gas volumetric flow rate Av- inside cross-sectional area of vessel

Vs = Qgas/Av

increasing Vs causes An increase in foam generation A decrease in P/V An increase in oxygen transfer

Overall, scaling up process parameters is tricky Each scale-up parameter is dependent on another
Cannot keep all constant during scale-up

Not one scale-up process is correct


Technicians determine which parameter is critical to the process and try to find a happy medium between each of the remaining parameter

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