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Accelerate development of GMP-grade production enzymes essential for manufacturing mRNA-based biopharmaceuticals.
October 14, 2021
By: Tim Wright
Editor-in-Chief, Contract Pharma
Cellumed Co. Ltd., based in Seoul, Korea, and Germany-based ARTES Biotechnology GmbH have entered a development and license agreement aiming at the generation of microbial production cell lines, processes and documentation for the cGMP manufacturing of two enzymes required in the manufacturing process of mRNA vaccines. Under this agreement, ARTES will be responsible for the development of high yield microbial cell lines expressing two recombinant enzymes. Further steps at ARTES will include the development of up- and downstream processes as well as of the analytical assays to characterize the two products. Results will be transferred by ARTES to its German CMO partner Richter-Helm BioLogics GmbH & Co. KG for subsequent cGMP production. The project management will be supported by ARTES´ Korean representative Quality by Design, Inc. Cellumed predicts that the mRNA platform will gradually expand product development in the future as a base technology with high potential for developing other vaccines and therapeutics even after COVID-19 subsides. Therefore, Cellumed will realize technological independence of materials through the localization of production enzymes, which are key raw materials for mRNA vaccines. In addition, it is planning to supply production enzymes in Korea first, and is also planning to gradually advance into the global market. “We are very proud being chosen by Cellumed for this important task of supporting the establishment of most up-to-date mRNA technology in South-Korea,” said Michael Piontek, managing director, ARTES Biotechnology. “We will contribute our long-term experience in recombinant biotechnology and will give all our outstanding expertise and know-how in this collaboration.”
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