The Company
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. The company is at the heart of the fight against the global pandemic being involved the development, manufacture and packaging of multiple vaccines to combat COVID-19.
With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 15,000 people, including around 2,500 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated $3 billion in annual revenue.
The Problem
Catalent produces Zydis®, the leading orally disintegrating tablet (ODT). The Zydis ODT fast-dissolve formulation is a unique, freeze-dried oral solid dosage form that disperses almost instantly in the mouth with no water required. It helps delivering treatments to patients and consumers who have difficulty swallowing conventional pills, or where rapid onset of action is desirable. Catalent is looking to improve membrane penetration of the ODT, which the company believes could be achieved through absorption enhancers, an agent that assists in the transit of pharmaceutical product from the patient’s mouth into their bloodstream. However, the company has very limited expertise in this area.
The Solution
The aim of the Knowledge Transfer Partnership (KTP) is to develop and prove an accurate predictive decision-making tool to pre-determine accurate levels of absorption enhancer for each Zydis product, potentially facilitating faster pharmaceutical development, improving efficiency, and reducing time to market.
"We are excited to be working with Aston University on this project. Aston's expertise in drug transportation, cell biology, data analysis and model cell line design, coupled with its world-class facilities means that together, we will be able to achieve significant improvements in efficiency, and accelerate new product development." Ralph Gosden, Catalent’s Head of Zydis Product Development.
Additional benefits of this KTP for Catalent include:
- Reduction of R&D costs by 75% over three years
- Increased volume of ODTs produced annually by 13.6%
- Improved competitive edge through more efficient development timelines to produce better products, reduce failures and accelerate product development for its clients
- Assistance in achieving 6.25% of the total market of ODT doses.
Team Aston
Academic lead on this project is Professor Afzal Mohammed, who is Chair in Pharmacy in the College of Health and Life Sciences (HLS) and a member of the Aston Pharmaceutics Group (APG) at Aston University.
“This is a great opportunity for us to share and translate our academic experience in cell-based models, excipient and formulation characterisation to develop an evidence-based predictive tool that has the potential to expedite product development at Catalent” said Professor Mohammed.
Professor Mohammed will be supported by other APG members, all of whom are pharmacy lecturers:
- Dr Dan Kirby’s research expertise covers drug delivery and his findings have highlighted the need for the development of novel formulations and alternative dosage forms to improve patient acceptability.
- Dr Affiong Iyire has research expertise in the formulation of drugs for pregastric absorption and has particular experience using and evaluating innovative cell models
- Dr Raj Badhan is a pharmacookinetics expert with vast knowledge of in silico methods.
Completing the project is associate Ruba Bnyan, whose research expertise covers lipsome preparation, controlled drug delivery and pharmaceutical formulation.
"The ultimate benefit of working on a KTP project is imbedding the innovation into your business partner and ensuring that smooth transfer accelerates their product development. Personally, the project allowed me to develop a set of skills beyond the technical and lab-based experience." Ruba Bnyan, KTP associate
Next steps
The KTP is expected to complete in August 2022 – look out for more updates by following us on Twitter and checking our webpage.
For more information about Knowledge Transfer Partnerships or an informal chat, email ktp@aston.ac.uk or call 0121 204 4242.