SOME ASPECTS OF TRANSFER AND SCALING OF TECHNOLOGY FOR PRODUCING A DRUG BASED ON L-ORNITINE-L-ASPORTATE

Abstract

Technology transfer is part of drug development. The process of transferring drug development to industrial production involves scaling the technological process. The aim of the work was to determine factors that may affect the quality of a drug based on L-ornithine-L-aspartate during the transfer and scaling of the technological process in industrial conditions. The object of the study was the drug L-ornithine-L-aspartate, a concentrate for infusion solution at a concentration of 500 mg/ml, as well as an assessment of the effectiveness of technology transfer processes at various stages, in particular the development, transfer, and adaptation of technologies to production conditions. The main scaling criteria were the use of equipment with oriental operating principles, forecasting possible deviations when scaling the technological process, determining additional critical process parameters and control points that were developed at the stage of pharmaceutical development of the drug in laboratory conditions. Based on the results obtained during the pharmaceutical development of a drug in the form of a concentrate for infusion solution based on L-ornithine-L- aspartate, the transfer and scaling of the technological process was carried out. Technological parameters and critical control points were determined at all stages of product production and their compliance with the data obtained during the development of the drug in laboratory conditions. Quality control results of experimental and industrial batches, which were developed on industrial equipment, meet the expected criteria, the results of control of these batches are close to each other, which indicates that the transfer from laboratory to industrial batches leads to the receipt of a product, which in turn meets the required quality indicators.