Modelling Approaches for Bio-Manufacturing Operations - Measurement, Monitoring, Modelling, and Control of Bioprocesses - page 85

Modelling Approaches
for Bio-Manufacturing Operations

Sunil Chhatre

Abstract Fast and cost-effective methods are needed to reduce the time and
money needed for drug commercialisation and to determine the risks involved in
adopting specific manufacturing strategies. Simulations offer one such approach
for exploring design spaces before significant process development is carried out
and can be used from the very earliest development stages through to scale-up and
optimisation of operating conditions and resource deployment patterns both before
and after plant start-up. The advantages this brings in terms of financial savings
can be considerable, but to achieve these requires a full appreciation of the
complexities of processes and how best to represent them mathematically within
the context of in silico software. This chapter provides a summary of some of the
work that has been carried out in the areas of mathematical modelling and discrete
event simulations for production, recovery and purification operations when
designing bio-pharmaceutical processes, looking at both financial and technical
modelling.

Keywords CFD Modelling Sensitivity analysis Simulation Window of
operation

Contents

1 Introduction.......................................................................................................................... 86

1.1 Overview of Bioprocess Modelling ........................................................................... 86

1.2 Advantages in Developing Bioprocess Models ......................................................... 87

1.3 Challenges in Developing Bioprocess Models .......................................................... 88

1.4 Technical Versus Business Modelling ....................................................................... 89

2 Setting Up a Model ............................................................................................................. 90

2.1 Establishing the Mathematical Basis for Modelling ................................................. 90

2.2 User Interfaces ............................................................................................................ 91

2.3 Modelling Inputs......................................................................................................... 91

2.4 Modelling Outputs ...................................................................................................... 93

S. Chhatre ( )

The Advanced Centre for Biochemical Engineering, University College London,
Gower Street, London, WC1E 7JE, UK
e-mail: [e-mail]

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