PRESS RELEASE: Icosagen AS started the construction of its GMP manufacturing facility in Tartu County
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.