Recommendations for Expounding Evaluation of Biological (Specific) Activity of Biotechnological Products in Product Specification Files

Biotechnological products, like all other medicinal products, have to comply with efficacy, safety and quality requirements. Quality evaluation of medicines includes assessment of test methods used to control medicinal product quality (described in product specification files provided by the manufacturer), laboratory testing of samples using these methods, as well as assessment of the registration dossier materials, including materials on test method validation included into the product specification files. One of the most important quality parameters of biotechnological products is biological activity, i.e. specific ability of a product to induce a desired biological effect. The article presents the results of a detailed analysis of methods used for determination of biological (specific) activity that are described in product specification files of various biotechnological products. The aim of the study was to demonstrate the importance of proper presentation of methods used for assessment of biological (specific) activity of biotechnological products and familiarise specialists engaged in elaboration of product specification files with the principles of presenting data in the «Biological (specific) safety» section. The analysis of documentation helped summarise the most common mistakes and omissions, formulate general recommendations concerning the description of methods, develop a general structure of the «Biological (specific) safety» section with detailed guidance on what to include in each of the subsections. Rationalisation of information presented in this part of the product specification files will help reduce the number of expert body’s requests for additional information/documents and will help ensure that laboratory testing is performed at a high professional level and within a prescribed period of time.