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Details of Grant 

EPSRC Reference: EP/V034723/1
Title: CMMI-EPSRC - Right First Time Manufacture of Pharmaceuticals (RiFTMaP)
Principal Investigator: Litster, Professor JD
Other Investigators:
Johnston, Dr BF Mahfouf, Professor M Coca, Professor D
Charitopoulos, Dr V Bogle, Professor I Salman, Professor A
Markl, Dr D
Researcher Co-Investigators:
Project Partners:
Alexanderwerk Gmbh AstraZeneca Eli Lilly and Company (International)
GlaxoSmithKline plc (GSK) IBM UK Ltd Lannett
Natoli Scientific Pfizer Process Systems Enterprises Ltd
Purdue University
Department: Chemical & Biological Engineering
Organisation: University of Sheffield
Scheme: Standard Research
Starts: 01 September 2021 Ends: 31 August 2024 Value (£): 1,543,633
EPSRC Research Topic Classifications:
Control Engineering Design Engineering
Design of Process systems Manufact. Enterprise Ops& Mgmt
Particle Technology
EPSRC Industrial Sector Classifications:
Manufacturing Healthcare
Pharmaceuticals and Biotechnology Information Technologies
Related Grants:
Panel History:
Panel DatePanel NameOutcome
08 Jun 2021 Engineering Prioritisation Panel Meeting 8 and 9 June 2021 Announced
Summary on Grant Application Form
The UK pharmaceutical industry produces 16% of the world's well-known medicines, employs more than 66,000 people (200,000 more indirectly) and contributes over £8.8 billion to the UK GVA. The current covid-19 crisis has highlighted the need for the UK and the USA to have a strong, smart pharmaceutical manufacturing base. The FDA in the USA has identified continuous pharmaceutical manufacturing as a highly promising solution to these challenges by enabling lower capital cost, smaller footprint and highly efficient facilities, which can be distributed geographically, improve national security by reducing dependency on foreign suppliers and can produce multiple products on demand with minimum risk to quality. However, the UK Government Made Smarter Review highlights that we still have a way to go to achieve a Right First Time smart manufacturing system as an enabler for the digitalization of continuous manufacturing in pharmaceutical industry.

Addressing these challenges are the domain of process systems engineers. By developing right-first-time (RFT) smart manufacturing systems incorporating Industry 4.0 concepts, we intend to address these key challenges in pharmaceutical manufacturing. Our hypothesis is that the development of a systematic framework for smart continuous pharmaceutical manufacturing can deliver key benefits to the industry including:

- Reduced time to market of new products;

- Reduced waste and increased resilience; and

- Reduced cost of manufacture.

To develop this framework, we have brought together a world leading team of process systems and pharmaceutical engineers from four universities in the UK and USA. An important and unique element of this proposal is the ability to validate state of the art models, control and optimization procedures on three cutting edge continuous manufacturing experimental platforms: (1) Consigma 25 wet granulation line at University of Sheffield (UK); (2) Dry granulation line at Purdue University (USA); and (3) Continuous direct compression line, also at Purdue.

The outcome of this project will be a framework and computational tools for optimal design of pharmaceutical processes with a real-time process management system and a flexible real-time release testing framework, all verified at pilot scale.

Key Findings
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Organisation Website: http://www.shef.ac.uk