Case Studies
The following case studies illustrate some of the past and current industry collaborations at the PMBRC.
Case Study 1: Development of novel drug delivery technologies with EirGen Pharma Ltd.
The PMBRC is involved with EirGen Pharma Ltd. in the development of novel drug delivery technologies for the treatment of eye disorders. Speaking of the collaboration, EirGen’s Technical Director Tom Brennan comments “EirGen’s involvement in novel drug delivery technologies moves the company up the value chain and away from generic product development which is the long term goal of the organization”. The details of this collaboration remain confidential between EirGen and the PMBRC.
Case Study 2: Innovation Partnership with Genzyme Ireland Ltd.
The PMBRC commenced a 3-year Enterprise Ireland innovation partnership research project with Genzyme Ireland Ltd. in June 2009. The project involves relating critical quality attributes of incoming raw materials to the performance of the manufacturing process. Further details of this collaboration remain confidential between Genzyme and the PMBRC.
Case Study 3: Identification of impurities in a tablet product for EirGen Pharma Ltd.
EirGen Pharma Ltd. required assistance with the identification of three unknown impurities in a tablet product, Eir-010, which were observed to form during stability testing. The company did not have the analytical equipment or expertise required to identify the compounds and approached the PMBRC to help.
The PMBRC has a suite of analytical equipment and trained researchers ideally suited to tackle this problem. Firstly the tablets were analysed by HPLC-MS and GC-MS to determine the molecular weight of each impurity. Tablets were then subjected to forced thermal degradation and appreciable quantities of each impurity were isolated using preparative chromatography. The 1H NMR spectra of the extracted impurities were measured at 400 MHz. The mass spectrometry and NMR data were then used to determine the identity of each impurity. The results were presented to the company in the form of a technical report.
The impurity problem was a significant hurdle in the development of Eir-010 and threatened to halt the filing of the product. EirGen were able to use the data generated to support the filing of Eir-010 with the European Medicine Agency (EMA). Eir-010 will be commercially launched in key European markets, with sales worth €20m forecast over the next five years. See IOTI flyer of this case study.
Case Study 4: Fluid Bed Drying Trials for Temmler Ireland Ltd.
Temmler Ireland Ltd. were looking to introduce a new product to their manufacturing site and requested the PMBRC to conduct fluid bed drying (FBD) trials on a granulate. The purpose of the trials was to determine the feasibility of drying the granulate using FBD prior to scale up in their manufacturing plant. The trials were successfully completed and the granulate characterised using the analysis equipment available in the PMBRC. Temmler are now planning to proceed with the new product introduction.
Case Study 5: Determination of tablet moisture content using near infrared (NIR) spectroscopy
NIR spectroscopy has become popular as a rapid analysis method for pharmaceutical products and intermediates. In this project, a PMBRC researcher worked on the development of a NIR method to determine the moisture content of a tablet product for a local pharmaceutical company. The method was rapid (< 30 seconds) and is to replace the existing moisture balance technique which is time consuming and labour intensive. The method was developed according to the EMA guidelines and involved the researcher spending a significant proportion of their time within the company.
Case study 6: Odour problem resolution in a medical device
A medical device company approached the PMBRC to identify an odour observed during normal usage of one of their products. This project is ongoing and will involve the use of GC-MS headspace analysis to determine the compounds responsible for the odour.