Health & Lifestyle

Advanced modelling and simulation technologies bring a step-change to design and operations

We reduced batch time for pharmaceutical grade lactose manufacture by 44%

Gerrit Westhoff
Friesland Campina

PSE's technology and services bring a step-change in capabilities to the Health & Lifecycle sectors, neglected for many years by the mainstream simulation vendors.

Innovative companies such as Procter & Gamble have pioneered model-based innovation and engineering approaches based on PSE's gPROMS modelling technology, to accelerate product development and improve manufacturing processes in many different areas.

Similar changes are occurring in the pharmaceuticals industry, where PSE customers now include the world's largest pharmaceutical companies.

What is driving this change?

Pharma companies in particular are facing commercial pressures for greater efficiency, better understanding of processes, more reliable scale-up, the adoption of Quality-by-Design (QbD) and the move from batch to continuous processing.

These are driving a much stronger focus on technologies such as process modelling to provide quantified decision support for process design and operation.

Benefits

There are many benefits that a model-based approach can deliver:

Faster time to market. Model-based techniques can shave 3-6 months off development, design and scale-up of production facilities.
Reduced cost of development of new formulations. It is possible to save millions of dollars through, for example, more efficient use of API in experimentation.

Publications

Quality through quantification – NextGen Quarterly Pharmaceutical review

Closer integration of R&D experimentation with process development to reduce development time and costs
Improved operational performance and lower production costs
Rapid and assured scale-up
Maximum manufacturing flexibility throughout a drug's lifecycle
Accurate quantification for implementation of Quality-by-Design (QbD).

Tools & services

gSOLIDS for solids process design and operations

gSOLIDS provides us with … a better likelihood that when we start up a new line it will work as planned.

Ben Weinstein
Procter & Gamble

PSE's process modelling software is specifically designed to deal with the complex processes encountered in pharmaceuticals manufacture.

We also provide comprehensive services via PSE Consulting that include methodologies for integrating experimental data within models to provide accurate scale-up.

Specific tools for pharma

gSOLIDS for optimising solids process design and operation
gCRYSTAL for optimising crystallisation process design and operation.

General-purpose modelling tools

gPROMS environment for high-fidelity predictive modelling of processes, a sophisticated tool for multi-scale modelling of complex processes and phenomena of all kinds
A comprehensive set of tools for model validation, including parameter estimation and model-based data analysis for deriving valuable design information from experimental data
The gPROMS experiment design option, for designing optimal experiments that maximise the information content

Batch-to-continuous

Modelling provides reliable quantitative information that minimises the risk in moving from batch to continuous production.

Batch process optimisation

gPROMS was specifically designed as a modelling tool for optimisation of batch processes.

Comprehensive tools for batch process optimisation, in addition to the tools for optimisation of continuous processes.
The Hybrid gPROMS–CFD Multizonal interface for linking CFD and reaction or cruystallisation models.

ModelCare model configuration, validation and execution services, for rapid project execution of all pharmaceutical modelling projects, and transfer of know-how to customer personnel

Services

Expert Consulting services, to analyse and formulate modelling requirements, execute model-based analyses, interpret results and advise on action – for example, appropriate experiments and measurement techniques
Model-Based Innovation services, to help integrate R&D effort with engineering design and operational improvement.