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Industrial plant : Hitachi

Hitachi

The appropriate growth conditions for organisms that are the catalysts for production in fermentation and bioprocesses depend on the characteristics of the organisms and the mechanical characteristics. We use simulations based on our long experience to understand factors such as flow in culture vessels, oxygen supply, and shear, and determine the appropriate culture equipment specifications.

(in-house comparison)

Applicable to Equipment for Bioprocessing

We use these simulators as part of our engineering and equipment design processes.

Applications

This can be applied to general agitation tanks. We are expanding engineering applications that use these simulators, mainly for culture vessels and especially cell culture vessels, which have various issues with physical damage and oxygen supply.

Using simulations to determine fermentor specification

The colored areas indicate where simulators and flow analysis have been applied.

Image: New planning direction for culture vessels
Enlarge image

Basis and significance of using simulations to verify design

[ICH Q5E (Equivalence and homogeneity evaluations that go with changes to production processes for biopharmaceuticals)]

We accumulate data to demonstrate the equivalence and homogeneity of products before and after a change to a production method, and this data becomes guideline for planning and conducting tests that confirm that changes to production methods do not cause adverse effects on the quality, safety, and effectiveness of final products.
When getting an understanding of how a change to bioprocessing will affect the equivalence and homogeneity of a product, it is important to accumulate knowledge through testing and get an understanding of the culture environment, including the metabolic characteristics (biological characteristics) of the produced cell.

Fields of application

This is appropriate for customers in this type of pharmaceuticals production business.

  • When increasing the scale of fermentor, customer want to prove the functional similarity of pilot data and actual equipment.
    Also in terms of validation, it is important to have scientific evidence for equivalence of pilot equipment and actual equipment.
  • Customers who want to optimize mechanical damage and shear force distribution and oxigen transfer rate for microorganisms, cells, etc. with high-quality, highly productive fermentors and fermentation plant.

Technology (Example of simulation results)

Simulation of shear force distribution in a fermentor

We change parameters such as the shape, dimensions, installation location, and rotation speed of the agitator impeller to optimize factors such as flow conditions, shear force distribution, and oxygen supply speed.

(in-house comparison)

Assessing cell damage due to shear force