On Wednesday, October 5th, the cGMP factory for the production of biological drugs developed by Icosagen AS, will have a cornerstone ceremony. The new factory will be integrated into the existing building and has been designed by the architects of Kauss Arhitektuuribüroo OÜ and the engineers ofAS TARI. Biotecha UAB Lithuania and Dunicom from Croatia were responsible for the design of the cGMP part, the complex will be constructed by Embach Ehitus OÜ.
The new manufacturing facility is 1,600 m2 in size and composed of two functional parts – laboratories and cell culture rooms are designed to be on the ground floor, andthe production unit with clean room conditions for the production of biological drug candidates for clinical trials will be on the second floor. The entire building with the cGMP part will be completed in June 2023, after which the qualification of the clean rooms starts together with the launch of equipment and optimization of production processes. This process will be followed by an application for a license for the manufacturing of medicinal products from the Agency of Medicines of the Republic of Estonia. According to current plans, the production of drug candidates in the cGMP facility will start at the beginning of 2024.
”The biological drug candidates produced in the factory provide an opportunity to produce clinical trial material, developed in cooperation between Icosagen and Estonian universities, for testing their efficacy and safety. In addition to its own candidate molecules, Icosagen can provide production services for pharmaceutical and biotechnology companies worldwide. The launch of this factory will lay the foundation for Estonia’s biological drug development industry,” said Mart Ustav, the founder and CEO of Icosagen.