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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.
”Embach Ehitus OÜ is pleased to contribute to the development of the production of innovative medicines. We will create a modern working environment for the employees and suitable premises for conducting tests and studies,” Andres Salusaar, the Chairman of the Management Board of Embach Ehitus OÜ commented.
“Icosagen’s biological pharmaceutical manufacturing plant allows us to expand our cooperation with other pharmaceutical companies in Europe and the USA to produce cGMP quality material for clinical trials. The chosen business model integrates Icosagen’s current business and, on the other hand, creates an independent production unit, the profits of which can be invested in Icosagen’s own therapeutic pipeline,” said Meelis Kadaja, Icosagen's Chief Business Development Officer.
The constructions are financed by a loan from AS Swedbank and negotiations are ongoing with the European Investment Bank to finance the construction of the GMP production unit.
Icosagen AS was founded in 1999 and employs more than 150 people. The therapeutic focus is on immuno-oncology, infectious diseases, and neuropathic pain treatment with antibodies and recombinant proteins. Several proteins developed and produced in Icosagen are currently used in clinical diagnostic as well as in Phase I and II clinical trials.
„Icosagen’s mission is to create a world-class biotechnology center in Estonia to help young professionals return home from abroad after their studies to carry out their professional careers here. We are determined to fulfil our mission to give excellence to Estonian science through improving the quality of people’s lives,” Mart Ustav added.
© 2024 Icosagen
