This thesis presents the possibility of using FTIR spectroscopy for the development of biological drugs. The basic concepts of FTIR spectroscopy are the interaction between infrared light and matter and the Fourier transform principle. The MIRA analyser is a state-of-the-art, high-performance instrument based on FTIR spectroscopy that can measure liquid samples.
The experimental work focuses on the benefits and challenges of FTIR spectroscopy, such as qualitative and quantitative characterisation of complex biological samples, protein secondary structure prediction, and detection of protein aggregation and glycosylation. Here, different samples (F1 and F3) with therapeutic proteins are analysed.
The performance, sensitivity and accuracy of the FTIR technique for the detection of changes in pH, concentration and aggregation of protein samples of finished pharmaceutical products were evaluated in the light of the results and the FTIR spectra obtained. It was found that the FTIR technique is suitable for the determination of pH, solution constituents from a qualitative and quantitative point of view, but not suitable for the analysis of samples with undefined composition.
The key findings are also that the FTIR technique is not the most suitable and efficient for all types of samples because it has some limitations, such as non-linearity over a wider measurement range and sensitivity with respect to the composition of the samples. It is suggested that further research on the FTIR technique for the analysis of biological medicinal products is needed.
|
