For its 90th anniversary, Farmak JSC launched new R&D laboratory and technology facility in Kyiv and plans to manufacture new science-intensive drugs, which will be compliant with the GMP requirements. The amount of investment is over UAH 100 million, for which Farmak plans to achieve payback over the next 2-3 years.
The new laboratory and technology facility will make it possible to conduct high quality development and promptly launch new medicinal products into market. The opportunity to manufacture similar products of the most recent generation will enable Farmak JSC to provide important import substitution to fill the niche of imported drugs in Ukraine with their domestic counterparts. The new facility makes it possible to set critical parameters, to build quality into the manufacturing process, and to achieve the target product profile as early as at the drug prototype stage.
The idea to create laboratory and technology facility with a pilot manufacturing site was a part of the plan to consolidate our R&D functions and close the gap which existed between development and manufacturing, says Andriy Goy, Head of R&D Department at Farmak JSC. Automated equipment, which provides downscaled reproduction of manufacturing procedures, and a whole multitude of state-of-the-art instruments to study physicochemical processes are now combined under the same roof. As a result, we obtained the scientific research and experiment area to test new and improve existing technologies for finished medicinal products.
The laboratories are provided with advanced technology equipment of such global manufacturers as Glatt, SBM, Urlinski, Belimed, De Ditrich, Gea, Sartorius, Malvern Instruments, and others. The design was produced by Unitechnology-UA, a Ukraine-based company, jointly with Farmak’s Design and Engineering Department.
The end-to-end principle of science and technology development implemented in the new R&D facility, from test tubes to pilot batches, makes it possible to conduct managed simulation, incremental scaling, technology transfer, and stand-alone preparation of test and clinical samples in GMP environment with the minimum intervention into the manufacturing operation plan.
Individual laboratory and manufacturing sites in the facility make it possible to develop and prepare hard dosage forms and aseptic liquid dosage forms in compliance with the GMP requirements.
As of today, the laboratory and technology facility is already producing clinical and registration batches; experimental batches are being prepared and their number is currently more than 150.
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