ADVANCED PROCESS MODELLING FOR PHARMACEUTICALS

PSE offers a unique mix of advanced process modelling software technology and expert services to the Life Sciences sector.

Increasing global competition, patent expiry and the cutting of health care cost in most countries are putting relentless pressure on the Life Sciences sector to continuously innovate and deliver new and improved products.

PSE is working with major pharmaceutical and bioscience companies to apply advanced process modelling techniques that enable rapid exploration of the design space and result in better, faster and safer decisions.

The recent changes in ICH regulations, together with Process Analytical Technology (PAT) and Quality-by-Design (QbD), are driving a much stronger focus on technologies such as first-principles process and system modelling.

Why use model-based techniques?

Model-based techniques – widely used in other areas of the process industries – allow companies to develop much deeper knowledge and understanding of their processes, as well as provide quantified decision support for process design, development and operation.

A model-based approach can deliver many benefits. It enables:

• Faster process development time: model-based techniques can reduce the time for development, design and scale-up of production facilities by 3 to 6 months
• Effective exploration of batch-to-continuous viability and implementation
• Reduced cost of development of new formulations. It is possible to save millions of dollars through, for example, more efficient use of APIs in experimentation.
• Closer integration of R&D experimentation with process development to reduce development time and costs and thus improve R& efficiency
• 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).

What we do

PSE provides a comprehensive set of software tools, capabilities and expert services for process design, optimization and operation.

World-leading software tools

PSE’s gPROMS FormulatedProducts environment for integrated digital design of robust formulated products and their manufacturing processes is unique in the industry.

Developed in close collaboration with leading pharma and consumer products companies Pfizer, Procter & Gamble, Eli Lilly, GSK, AstraZeneca and Roche, it provides powerful mechanistic modelling capabilities for design and optimisation of drug substance manufacture, drug product manufacture and drug delivery.

Because gPROMS FormulatedProducts is built on the powerful gPROMS advanced process modelling platform, it can take advantage of all the core platform features: steady-state and dynamic modelling, extensive custom modelling capabilities, rigorous advanced parameter estimation, mixed-integer and dynamic optimization capabilities, global system analysis, and many others.

A powerful TASK language allows definition of complex operating procedures, and there are comprehensive tools for batch process optimization. A Hybrid gPROMS–CFD Multizonal interface is available for linking CFD and reaction or crystallisation models

Services

PSE is not just a software company, but works in close co-operation with major players in the Life Sciences sector to deliver fit-for-purpose solutions.

Our PhD-level team of domain and modelling experts provides services to augment R&D efficiency that include:

• ModelCare model configuration, validation and execution services, for rapid project execution and transfer of know-how to customer personnel
• advice on appropriate experimentation and measurement techniques
• advice on methodologies for integrating experimental data within models to provide accurate scale-up
• Model-Based Innovation services, to help integrate R&D effort with engineering design and operational improvement
• Training and support.