One of the key challenges in the development of up-to-date domestic pharmaceutical technology is the lack of effective preparative methods for the fractionation of target substances. In particular, the release and purification of regulatory peptides from extracts of animal tissues requires multistage schemes because the molecular sizes of the peptides are small (1–2 nm), their content in the feedstock does not exceed 1–2%, and the accompanying natural macromolecules have various functional groups for peptide binding and interaction with them.
Our company solved the task of fractionating such systems with modern polymeric materials, track membranes and domestically produced hypercrosslinked ion exchangers with a regulated nanostructure.
The use of such materials requires a certain modification of the process equipment design. In developing methods for the fractionation of polydisperse molecular systems, particular features of hydrodynamic flows of viscous solutions in nanocapillaries of membranes and submicron drainage elements of mass exchangers were taken into account.
A significant advantage of the developed molecular nanotechnology is the exclusion from the flow diagram of organic solvents, which meets the environmental requirements for new chemical technologies.
Regarding the peptide substance synthesis, it can be noted that there are manufactures in Russia (Bion and others) that meet international standards for the peptide substance synthesis. There are also many foreign companies specialising in the production of synthetic peptides (Bachem etc.).
Contemporary trends in the industrial production of peptide substances for the pharmaceutical industry consist in the balanced use of synthesis methods in solution and on the solid phase as well as the increased use of enzymatic and biotechnological methods.
The key area of further improvement is the use of increasingly sophisticated cleaning and analytical quality control methods.