About Catalent
Catalent is a global leader in enabling pharma, biotech, and consumer health partners to optimise product development, launch, and full life-cycle supply for patients. With broad expertise in development and analytical services, delivery technologies, and multi-modality manufacturing, Catalent is a preferred contract delivery and manufacturing organisation (CDMO) for personalised medicines, blockbuster drugs and consumer health brand extensions.
The challenge that the KTP was set up to address
Catalent’s proprietary Zydis® orally dissolving tablet (ODT) technology enables the rapid absorption of active pharmaceutical ingredients (APIs) through pre-gastric delivery, which is often preferred because it allows the drug to be absorbed much faster. However, many APIs have poor pre-gastric absorption and need to be combined with suitable excipients, or additives, to bind the active ingredients and speed up the process of dissolving and absorbing via the pre-gastric route. Candidate excipients were proving difficult to identify efficiently via the existing empirical approach and to address this challenge, there was a need to develop a more systematic approach for excipient selection.
Why a KTP was the ideal route
Catalent collaborated with Aston University through a Knowledge Transfer Partnership (KTP) to develop a decision-making tool for selecting suitable excipients for individual APIs.
Aston University’s project supervisor, Professor Afzal-Ur-Rahman Mohammed, has expertise in the design and optimisation of ODT formulation, as well as in the development of selection matrix tools for this purpose.
The Aston University team also has expertise in ‘buccal cell’ modelling – an in vitro cell model, in which cells are grown to represent the membranes in the mouth. This model then allows the screening and testing of various combinations of drugs and other excipients. Aston University had itself developed and published this novel model so owned the necessary technology and knowledge.
The KTP Associate chosen for the project, Dr Ruba Bnyan, has a master’s degree and a PhD in pharmaceutical drug formulation, as well as experience in cell-based models. She was keen to work with industry to see the impact of research.
What has changed as a result of the KTP?
The KTP has led to the successful development of a selection matrix, where, based on the API properties, Catalent formulation scientists can quickly identify excipients that will improve the pre-gastric absorption profile. Adopting this novel tool allows for quicker and more efficient drug development and has the potential to increase the number of Zydis ODT candidates in the pipeline for future development.
“The selection matrix gives scientists more control and more predictive performance of each formulation, as opposed to a trial-and-error approach with accompanying wasted effort,” says Professor Afzal Mohammed.
Broad benefits and impacts for all partners:
For Catalent:
The selection matrix is an evidence-based predictive tool that has the potential to expedite product development and allow for faster timelines, improving efficiency, and reducing time to market for clients.
For Aston University:
The university has demonstrated how its buccal cell model can have a direct impact on valuable drug development work, and the KTP project has established a close and trusted relationship with a leading organisation in the global pharmaceutical industry. The work has also generated a separate, subsequent KTP project.
For KTP Associate:
As a recent PhD graduate, Dr Ruba Bnyan took ownership of the project, running the lab experimentation process and writing reports, as well as transferring the knowledge to Catalent staff. This gave her valuable scientific research and teaching experience.
What the partners say:
Desmond Wong, Product Development Supervisor at Catalent:
“This project has exceeded our initial expectations and has the potential to accelerate product development for our clients. Our strong relationship with the Aston University team on this KTP project highlights the transformative potential of collaborative research and its impact on pharmaceutical innovation.”
Dr Ruba Bnyan, KTP Associate:
“Leading the project and keeping it on track, as well as delivering the training to Catalent, was hard work but enjoyable. In addition, I have learned valuable experience in working with the Catalent team.”
Professor Afzal-Ur-Rahman Mohammed, Aston University:
“This has been a very successful project, which has been rated as ‘Outstanding’ by Innovate UK. We plan to put it forward for a KTP award and are looking forward to continuing working with Catalent on our next KTP project.”