Biotech drugs: what are they?
Humanity now uses a huge number of biotech drugs without thinking about their origin and production process. Such drugs include, for example, insulin, hormonal drugs, vaccines, etc. Biotechnology (BT) drugs account for 29% of sales in Russia. BT drugs are expected to account for 35% by 2026. What does a “biotech” drug mean? What is its difference from “chemical” and how is it produced?
- Biotech drug.
There are several definitions of a biotech drug. According to Decision No. 78, which is key for drug registration,
“biological drug” is a drug where active substance is produced or isolated from a biological source. To describe its properties and to conduct quality control, combination of biological and physical and chemical analysis methods with an assessment of the production process and control methods are required.
One important detail is missed in this term, namely the root of -techno-. It is very important to understand that the production of such drugs uses living systems (-bio-) that provide synthesis of targeted molecules that are impossible or very difficult to recreate synthetically. However, one cannot omit the technological component of the process. After all, it is due to a carefully established and standardized process that biotechnology operations are generally possible.
In connection with the above, the most appropriate definition of a biotechnology drug is the definition of the biological drug, given in FZ No. 61:
biotech drug – drug produced using biotechnology processes and techniques (including DNA recombinant technology, technology of controlled expression of genes encoding biologically active proteins in prokaryotes and eukaryotes, including altered mammalian cells), the hybrid method and monoclonal antibody method.
- How are biotech drugs produced?
The production of each biotech drug involves a large number of nuances that depend primarily on the properties of the produced molecule, as well as on other factors. However, there are some operations that the biotechnology process can rely on. For example, DNA recombinant technologies.
Recombinant DNA technology (molecular cloning, genetic engineering) is a collection of procedures that allow the transfer of genetic material (DNA) from one organism to another.
In other words, if we need to get an insulin drug, we can transfer DNA “with instruction” for insulin synthesis from the human body to the microorganism (e.g., E. coli) and force the bacterium to produce insulin despite the fact that E. coli is not capable of doing so in natural conditions.
The invention of this technology was a breakthrough for medicine and allowed to produce, for example, highly purified insulins as well as other vital drugs.
- Fundamentals of Pharmaceutical Biotechnology: Tutorial/T.P. Prischep, V.S. Chuchalin, K.L. Zaykov, L.K. Mikhaleva, L.S. Belova. — Rostov N/d.: Phoenix; Tomsk: NTL Publishing House, 2006. — 256 p.
- Federal law “On the circulation of medicines” of 12.04.2010 No. 61-FZ (last revision)
- Decision of the Council of the Eurasian Economic Commission dated 03.11.2016 No. 78 (ed. 23.12.2020) “On the Rules of Registration and Expertise of Medicines for Medical Use”