Abstract
A new class of biologics is obtained using the technologically processed of antibodies (TPA), which are used as the initial substance, and their dilution at each stage is accompanied by a controlled external vibrational (mechanical) treatment. This article focuses on the development and validation of a novel technique that can be applied for assessing the identity of TPA-based drugs. It has previously been found that after such treatment, the resulting solution either acquired new properties that were not present in the initial substance or a quantitative change in properties compared to the initial substance was observed. The use of mechanical treatment during the manufacture of the TPA-based drugs can cause the formation of new bonds between the solvent and antibody molecules. These changes manifest themselves in altered adsorption at the surface of the test solutions, which results in the formation of a near-surface film. One of the indicators of such events is the change in the surface temperature of the solution, which can be analyzed using high-resolution thermography. Unlike other methods, the high-resolution thermography allows the near-surface layer of a heterogeneous aqueous solution to be clearly visualized and quantified. A number of experiments were performed: seven replicates of sample preparations were tested; the influence of factors "day" or "operator" was investigated during 12 days of testing by two operators. The method also allowed us to distinguish between technologically processed antibodies and samples containing technologically processed buffer. The thermographic analysis has proven to be a simple, specific, and reproducible technique that can be used to analyze the identity of TPA-based drugs, regardless of the dosage form tested.