DEVELOPMENT OF A METHOD FOR QUALITY CONTROL OF PEPTIDE DRUGS WITHOUT OPENING THE PRIMARY PACKAGING

Objective: The purpose of our study is to search for a new express method for quality control of peptides and polypeptides based on their authenticity. Methods: Aqueous solutions of animal and plant-derived regulatory peptides, experimental compounds and finished therapeutics, finished dosage forms of animal tissue extracts (a mixture of peptides and polypeptides from tissues) and drugs with active pharmaceutical ingredient in which solutions of anti-bodies to interferon γ were applied on a carrier in the fluidized bed chamber have been studied by methods such as: dynamic light scattering (DLS) for determining the size distribution of density heterogeneities, method of two-dimensional dynamic light scattering (2D-DLS) and method for determining radiothermal emission using a broadband radiometer to specific identification of peptides and polypeptides drugs without opening the packaging due to the individual data set of each biomolecule. Method of solid phase peptide synthesis based on the FMOC technology Results: The data obtained indicate that biologically active peptides and polypeptides can induce heterogeneous densities within the submicron (100–1000 nm) and micron (5,000–6,000 nm) ranges. These specific induction patterns were used as individual characteristics of each peptide or active pharmaceutical agent. These were detected using the two-dimensional dynamic light scattering (2D-DLS) method. For example, peptides derived from the same plant (StSys1) and (StPep1) can be easily distinguished at nanomolar concentrations. This approach demonstrates the creation of a unique “fingerprint” for each peptide preparation. In addition, it has been found that solutions containing peptides, which are biologically active nanoparticles with complex shapes, not only emit within the millimeter wavelength range but can also mimic their presence within cells by activating giant clusters. Conclusion: The interaction of peptides and polypeptides with aqueous solutions leads to remote anomalous induction of water clusters. The spectrum of sizes of these giant heterophase water clusters, the kinetics of their flickering, and millimeter-wavelength radio emission open up the possibility of express control of peptide-based drugs by their "authenticity" characteristic without opening the packaging. © 2025 Elsevier B.V., All rights reserved.