Technical Director of JSC “Farmak”

Aug 13, 2019

Compliance – proven!

However, Filya Zhebrovska, Chairman of the Supervisory Board of JSC “Farmak”, always set a very high standard. The decision to prove the bioequivalence of new and existing medicinal products manufactured by Farmak was exceptional. It was a unique event for the entire industry: nobody had ever decided to invest in such a complicated and lengthy process before, and this was not required by the regulatory authorities. But far-sightedness has been always a feature of our Company. The step of planning in Farmak is 5–10 years. This makes it possible to maintain leadership positions in the Ukrainian market and be among the first to introduce modern technologies in production.

This project has become a driver bringing our technological excellence in the manufacture of solid dosage forms to the golden standard level. The far-sighted solution gave an impetus to a technological leap and a new level of the culture of generic development. It is not just about analysis of the active substance and excipients; it also takes complex bioanalysis, considering numerous variables, and very sensitive methods. For instance, sometimes we deal not even with nanograms, but with trace amounts of substances!

Eventually, a product we will offer should represent the entire target biopharmaceutical profile. This means that numerous aspects should be considered: not only the molecule itself, but the configuration of its crystals, degree of dispersal of particles, etc. And now, what was new for us 10 years ago has become common practice. We are confident that we offer generic drugs that are proven to have the same effect as the original ones. Doctors are every time convinced of this and treat our products with great respect.

The processing of a seemingly familiar drug sometimes used to require more effort than the creation of a generic one. In any case, bioequivalence studies make the process of drug development longer. It may last for a year, year and a half, or even more. Sometimes it took dozens of batches to achieve ultimate equivalence… Fortunately, in about 80 per cent of cases the process was smooth. However, the team is not embarrassed about those 20 per cent when the desired result could not be achieved at the first attempt, and it was necessary to refine the technology, adjust the formulation or

change the study design. Such temporary failures, indicating the absence of falsifications, were evidence of transparency and reliability of our approach. We did not submit the medicinal product for registration until we obtained positive results with all required statistical accuracy and full compliance with all European guidelines and criteria.

To make sure that the laboratory prototype maintained all the required parameters in the batch production, the Company created a pilot site with miniatures of technical equipment. This allows simulating and elaborating the process in every detail. Further, during commercial-scale manufacture, compliance with the set requirements is ensured by GMP standards. Thus, the art of searching, science of simulation and practical direction of engineering is supplemented with another crucial parameter: reproducibility of the excellent result. Farmak’s modern equipment allows making up to 200 tablets per second, with each of them being in full compliance with the target profile.

The team working on bioequivalence studies is really a cool team. Due to it, our Company has a comprehensive scientific and practical center. Doctors, candidates of science – our employees – work in the field of pure science and at the same time use its achievements to address applied problems. Among all scientists working on theoretical intelligence, our colleagues are distinguished by multidisciplinary thinking skills: the ability to design a technological process, manage the cost of components. Therefore, I am convinced that the potential of our team will grow in the future.
Today, Farmak is a strong technological cluster integrating most of the modern processes used in the pharmaceutical industry at the commercial level. Therefore, its objective is to be the leading center of pharmaceutical technology and to quickly adapt unpatented innovations, reduce their cost due to sophisticated solutions, and make modern pharmacological therapy affordable. This is a very significant contribution to the healthcare system of Ukraine, as well as other countries, where Farmak is present.

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