Case Study Template

Case Study

Target Healthcare + University of Strathclyde

Assessment of shelf-life and stability of a range of aseptically prepared Monoclonal Antibodies (MABs) for patient use.

Awards and Achievements

KTP Final Grade: B ⭐⭐⭐⭐

The project was awarded the grade of "Very Good" by the KTP Grading Panel for its achievement in meeting KTP's objectives.

Target Healthcare

Target Healthcare Limited is a manufacturer and wholesaler of a wide range of pharmaceutical products, including generic, branded and unlicensed medicines.
The business was founded in 2012, and is headquartered in East Kilbride, South Lanarkshire. In January 2017, our Target Luton site was created, when Target acquired Temag Pharma in the Greater London area. The site has a purpose-built, and state-of-the-art manufacturing suite.

KTP Associate Seminar Presenation

The Challenge

The compounding of the mAb to syringes or IV bags is carried out under aseptic conditions, therefore the risk from a microbiological point of view is minimal. From a chemical and physical point of view a robust study must be designed to determine if changes can be seen in the product over time. The assays which will determine changes to chemical & physical properties of the product have been identified as Appearance, pH, Size Exclusion HPLC (SEC-HPLC), ELISA, Capillary Electrophoresis – SDS both reduced and non-reduced and Capillary Isoelectric focussing (CIEF). All of these methods require to be developed and validated to show they are fit for purpose.

The Solution

Once all assays have been validated, a stability study is required to be designed to analyse these assays at time-point zero, then after we have a baseline after 14, 35, 70 & 105 days incubation at 2-8^oC. In addition to this sample will be incubated for 48 hrs, at ambient conditions, after each sample is removed from each time-point. This allows for additional information on the shelf-life at ambient for events when the sample is left out in error by the clinic.

The results from each time-point will be compared to the time-point zero result and any changes will be assessed. If the study is successful, it will allow the company to extend the shelf-life to 84 days at 2-8^oC & 48 hours at ambient, from the current shelf-life of 24 hours at 2-8^oC & 12 hours at ambient. The regulations state that the shelf-life can only be extended to 80% of the overall study period, which in this case is 105 days.

The Impacts and Benefits

Impacts for the Company

Target Healthcare benefited from the development and validation of new analytical methods that now support the extended in-use shelf-life of monoclonal antibodies.

The company’s operational capabilities were enhanced by incorporating the knowledge transferred by the Associate, including tailored training for internal staff and a more robust framework for stability assessment.

The revised protocols and validated methods have not only improved internal processes but have also positioned the company to compete more effectively in the market by potentially extending the shelf-life from 24 hours to up to 84 days under controlled conditions.

Impacts for the Academic Team

The KTP has enhanced teaching by integrating real-world industrial challenges and outcomes into the curriculum. The project's work on developing and validating advanced analytical methods to extend the in-use shelf-life of monoclonal antibodies has provided valuable case study material, enabling students to explore topics such as method development, validation, and risk management within a commercial pharmaceutical environment.

The knowledge and experience gained through the project have informed updates to Master's and PhD programmes, ensuring that teaching reflects current practices in pharmaceutical analysis and stability testing. By incorporating practical examples and industry-led insights, the KTP has strengthened the link between academic learning and industrial application, helping to develop students' critical thinking, problem-solving abilities, and preparedness for careers in the pharmaceutical sector.

Impacts for the KTP Associate

Through the KTP, Yvonne significantly expanded her technical expertise by developing knowledge and experience in assay methodologies.

The Associate development budget provided access to specialist training opportunities that would otherwise have been difficult to undertake due to time and cost constraints. This included project management training, enhancing Yvonne’s ability to manage complex projects within the pharmaceutical sector.

Regular engagement with the KTP team at quarterly meetings, helped Yvonne build confidence in communicating technical information and strengthened her professional and leadership skills.

Meet the Team

Yvonne Doyle

KTP Associate

Professor Yvonne Perrie

Knowledge Base Supervisor

Bridgette McGeever

Company Supervisor