The Centre of Excellence (CoE) for Pharmaceutical Formulation & Manufacture provides a single-point service for material and equipment characterisation as well as predictive modelling.

This helps pharmaceutical companies accelerate the development of drugs and their manufacturing processes, from R&D through tech transfer to commercial manufacturing.

Depending on your requirements, the CoE can work collaboratively with your experts or provide complete turnkey solutions.

Approach & vision

The CoE, which comprises PSE and the Research Center Pharmaceutical Engineering (RCPE), uses an integrated and holistic approach that combines the following technologies and services:

Mechanistic process modelling

PSE’s gPROMS FormulatedProducts® environment provides integrated design & optimisation of formulated products & their manufacturing processes, including extensive capabilities for processing experimental data.

Discrete element modelling

RCPE’s XPS (eXtended Particle Simulation) CFD-DEM software for the particle processing industry predicts the behavior of several million solid particles and their interaction with surrounding fluid flow in arbitrary complex geometries.

Experimentation service

RCPE’s state-of-the-art experimentation facilities and services allow rapid setup and execution of experimental programmes to support drug development and manufacture.

Better tech transfer

One of the key benefits of an integrated approach that combines mechanistic modelling and experimentation is faster and more confident tech transfer.

What are the benefits of working with the Centre?

The CoE helps companies to achieve a faster time-to-market with new products, through the ability to explore options rapidly using predictive technology and a knowledge-driven approach. Specific benefits include the ability to:

  • design more robust manufacturing processes, leading to saving of time and money and increased quality and regulatory compliance
  • accelerate formulation decisions, helping to identify and mitigate critical risk factors – for example, CQAs
  • better-managed technology risk for novel manufacturing routes, helping to identify identify CPPs and their PARs
  • more efficient R&D through integrated experimentation and modelling, leading to increased R&D efficiency, with less lab time and API consumption
  • more knowledge and understanding and more reproducible information, leading to better return on PAT investment.

The benefits of a streamlined business relationship

The Centre of Excellence offers clients a much wider range of integrated experimental and model-based solutions than the partners can alone, with seamless support across this wider range of solutions.

What is more, this can be covered by a single commercial agreement and legal agreement and overseen by a single point of contact (if desirable from the customer’s perspective).

More Information

The CoE deploys an integrated, holistic approach

What the partners say…

The combination of mechanistic models and experimental data is a very powerful approach that helps pharma companies to accelerate drug substance and product development, understand and manage risk, and design and scale-up robust manufacturing processes.
SEAN BERMINGHAM - VP FORMULATED PRODUCTS, Siemens PSE
The Centre of Excellence gives us a truly unique capability and allows us to provide a unique set of services via a single-point contact.
MASSIMO BRESCIANI - DIRECTOR, RCPE