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.

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

What was the need?

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.

What did we do?

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.

What changed?

The Impacts and Benefits

Impacts for the Company

The stability studies enable the business to support more patients across the UK to access urgent medications as efficiently as possible. Improving product stability enables products to be prepared in a more timely manner and ensures that products are available as soon as required to treat critical illness. Not only can the company improve patient access but can also reach a wider patient group by having more readily available compounded medicines.

Impacts for the Academic Team

Although the project does not affect the academic team and there will be no lasting legacy such as published papers (due to Intellectual property restrictions from the company), with the associate working in the CRUK labs she has been able to pass on her knowledge from previously working in and industry laboratory. This was important as the University had not previously had a CZE system, the associate had used this system in her previous workplace and was able to help troubleshoot all the issues she had seen

Impacts for the Knowledge Exchange Associate

The KTP Associate benefits from: The gap in knowledge for assays that they were not experienced in. The professional development budget, which allows the associate to progress with courses previously unavailable to them due to the cost and time. I have been able to access Project Management courses which are relevant in the pharmaceutical field. I have also gained confidence with the support from the KTP, University & the company during quarterly LMC presentations throughout the project.

The People

Meet the Team

Yvonne Doyle

KTP Associate

Professor Yvonne Perrie

Knowledge Base Supervisor

Bridgette McGeever

Company Supervisor