Investigation of specificity ensuring of quality of biological medicinal products on example of drugs Cortexin and Retinalamin

Abstract

Biological medical products nowadays are one of the most promising area at the pharmaceutical market. Biopharmaceutical market has significant benefits such as fast and effective development of production facilities, the development of more effective and safer medical products.

The aim of our research was, on the example of medical products Cortexin and Retinalamin, examine the specifics of quality of biological medicinal products in the chain from production to sale.

The objects of study - original biological medicines Cortexin and Retinalamin. Comparative, systematic, analytical methods and reviews were used.

Biological medical products have fundamental differences from synthetic medicines, due to their source - alive cells which are usually used in their production process. Each production cycle results in a unique finished pharmaceutical products and minimal differences in the modes of production can significantly effect on the properties of biological medical products. Therefore, even if the physical, chemical and biological properties of the product thoroughly studied and described, it does not guarantee therapeutic equivalence of two biological products which are manufactured in different conditions. One of the most important issues today is the problem of maintaining properties and quality of biological medicines. These issues are actively resolving on the native pharmaceutical market: quality control system are developing and implementing in accordance with international standards in order to maintain maximum efficiency of biological medicines and to protect consumers from defective products. Biological products require special conditions of storage and transportation. In order to save physical, chemical and therapeutic properties, strict compliance with the relevant conditions of packaging, transport and intermediate storage, related to deviations in temperature during transportation and storage is needed. The production process consists of the following stages: preparing of the solution for bottling, sterilizing filtration, washing and sterilizing of the bottles, aseptic filling, freeze drying and plugging, seaming, continuous monitoring in bulk. After getting the quality certificate and declaration of conformity products are transferred to the storage place for finished products.

The specificity of differences between biological medical products and synthetic medicines was investigated. Stages of ensuring of the quality of biological medicinal products with considering of particular qualities of the critical points were considered - the special conditions in the manufacturing process, temperature monitoring, systems and procedures of ensuring in quality during transportation, storage. The main stages of ensuring of quality were studied on the example of original drugs Cortexin and Retinalamin in the chain from production to sale.

Key words: biological medical products, ensuring of quality, Cortexin, Retinalamin.