Standardization of Medicines Biological

Standardization of drugs is an important stage in the production of medical products. In the case of biological medicinal products, this step is of particular importance. Biological drugs are produced from living organisms and can have a large number of variations in structure and function, making the standardization process complex and multi-step. One of the important tools for the standardization of biological medicinal products is their biological valorization.

Biological valorization (or standardization) is a process in which a biological product is compared with a reference product of the same type. The reference drug has known physicochemical and biological properties, so comparison with this drug makes it possible to establish the correspondence or difference between the drugs. In case of deviation from the reference product, measures can be taken to correct the problem.

The biological valorization process involves many steps, starting with the selection of a reference drug and ending with testing the drug against certain standards. One of the key steps is the assessment of the biological activity of the drug, which can be determined using various biological tests.

Standardization of biological drugs has a number of advantages. Firstly, this makes it possible to ensure the consistency and stability of the drugs, which is important for their effectiveness and safety. Secondly, this allows you to compare different drugs with each other and evaluate their effect. Finally, standardization is an important stage in the registration of medicines, which helps ensure their availability and widespread distribution.

It should be noted that the process of standardization of biological drugs is complex and requires highly qualified specialists. In addition, the process must comply with international standards and regulatory requirements. However, thanks to standardization, biological drugs are becoming more effective and safer for patients, making them an important tool in the treatment of various diseases.

Standardization of biological drugs (syn. valorization) is the process of establishing standards for the quality, effectiveness and safety of drugs of biological origin.

Biological drugs are obtained from living organisms or their products using biotechnological methods. These include vaccines, serums, enzymes, hormones, monoclonal antibodies and other protein preparations.

The main goals of standardization of biological products:

1. Ensuring the stability of their quality, efficiency and safety during production and storage.

2. Identification of counterfeit and counterfeit products.

3. Creation of uniform requirements for analytical methods of quality control.

4. Harmonization of domestic and international standards in this area.

The main areas of standardization: development of pharmacopoeial monographs, creation of general pharmacopoeial monographs, validation of analytical methods, certification of production according to GMP. Standardization ensures reproducible quality, efficacy and safety of biological products.