Roman Smishko

Head of RnD department

Nov 08, 2018

Technologies: continuous improvement

Today, Farmak can proudly say that the Company has sufficient scientific potential to meet about any requirements of marketing experts concerning relevant medicines.

Looking back years ago, we will certainly see quite noticeable differences in the requirements to the manufacture of medicines for the Ukrainian market and for European or American ones. Since Farmak JSC is guided by the highest standards, the Company has introduced a number of innovative improvements to comply with international requirements. However, global pharmaceutical industry does not stand static, so we need to be able to think ahead. New achievements become possible due to such key factors as development of an R&D center, production of own APIs and vertical integration of development, creation of modern production facilities, which enables the manufacture of complex and innovative drugs, building capacity in the field of biotechnology.

The Company’s main value is friendly and skilled staff. The R&D Department is no exception; we are proud of bringing together reputable scientists and talented youth. However, they also need technology to implement their potential. This is why, over the past 10 years, the laboratory of the research center was equipped with state-of-the-art analytical and technological equipment. Complex analytical tests carried out during clinical studies ensure that our products conform to the original ones. Due to a site where industrial technologies are reproduced on a pilot scale, we feel positive that all the required process parameters and quality indicators will be exactly as defined by the original product profile, when switching to commercial production.

Production in Shostka requires the development and introduction of new substances. Therefore, a separate API synthesis laboratory aimed at strengthening the Company’s focus on vertical integration of development was created in 2017. Twenty new substances are to be introduced in the near future. This is possible due to technological capacities: the site has modern laboratories, uses the innovative methods of manufacture. In particular, attention should be paid to flow synthesis unit, allowing to deploy new methods of producing substances that are impossible or too costly to manufacture through conventional synthesis. Innovative technologies not only help optimize and accelerate processes, but also facilitate much more complex synthesis than is possible in a conventional reactor used in the pharmaceutical industry. Obviously, the ability to produce own APIs is of great benefit for the Company, as it means independence from substance vendors, confidence in quality, rapid achievement of desired results.

Once Farmak started to exist as a chemical plant; in the 1990’s, manufacture of finished dosage forms, solutions and tablets was launched; these were quite simple products at first. Today, we can offer the market high-tech modern products: drugs in liposomal forms, emulsions, suspensions, prolonged-release tablets, the manufacture of which requires comprehensive knowledge of both the product, and the process and equipment, as well as ongoing monitoring. These models are called ‘Design space’ and ‘Quality by design’. The Company uses them and implements elements of continuous process validation in routine production operations with each and every new engineering project.

Proactivity and far-sightedness are the key elements of modern R&D. Biotechnology is a hallmark of a successful pharmaceutical company. The most notable discoveries of modern pharmaceutical science are in the field of genetic engineering and biosynthesis. In order to keep up with the time, we have created and equipped a modern biotechnological laboratory. In the long term, we intend to manufacture biotechnological substances, which will become the basis for own production of biologicals.

Summing up, we can once again emphasize: the Company has strong technological and scientific potential. Medicines that we offer to the Ukrainian and foreign markets comply with international quality standards. Therefore, the improvements that have occurred over the past 10 years continue unabated and give us confidence in the development and achievement of higher grounds, both in Ukraine and globally.

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