The production of biological and biosimilar medicines, where quality, safety, and efficiency are crucial, has recently significantly increased. Due to the structural complexity of these medicines, we have to monitor the emerging product during production. The purpose of our master's thesis is the implementation of the spectrophotometric analytical method that uses a variable optical path to determine concentration of proteins and other compounds. Since this was our first time we encountered such a determination in the quality control laboratory, we initially undertook the qualification of the SoloVPE system. This system measures absorbance at different path lengths and determines the sample concentration using an equation based on Beer-Lambert Law. During the installation qualification, we installed the Cary spectrophotometer, computer and ViPER software. This was followed by an operational qualification, where we aligned the optical cable, checked the connector and conducted a quick test for optimal system performance. We checked if the system achieved the appropriate light transmission value after installation. In the next qualification step, we performed a validation test to confirm the correct installation and operation of the system. The validation test consisted the light transmission test, the pathlength repeatability test and the linearity test. After successfully completed these qualification steps, we proceeded with the transfer of the analytical method. We transfered it from a laboratory where it was already validated. We checked whether the quality control laboratory in Mengeš meets the appropriate operational standards for in-process sample analysis. The test samples were selected based on the matrix, expected protein concentration and representativeness for the intermediates of our project. The results were evaluated according to the acceptance criteria for the analysis and method transfer. While performing analyses on the SoloVPE, we also noted differences compared to analyses performed with the classical UV-VIS method. We observed several disadvantages of the classical UV-VIS method, such as the longer preparation time, the caution required to avoid sample depletion and the time-consuming of analyzing a single sample. Given the compliance of all results with the acceptance criteria, we can confirm that we have achieved our objective after completing the qualification and method transfer. The quality control laboratory in Mengeš has been qualified to perform analyses using the SoloVPE system and the analytical method has now become part of the established analytical methods.
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