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ARTES and Cellumed accelerate development of key GMP-grade production enzymes needed for mRNA-based biopharmaceuticals
Langenfeld, Germany: – ARTES Biotechnology, the German-based biopharmaceutical CRO specializing in process development for recombinant vaccines, today announced it had reached a Development and License Agreement with South Korea’s Cellumed Co. Ltd. for generation of microbial production cell lines, processes and documentation for the cGMP manufacturing of two enzymes required for manufacturing messenger RNA (mRNA) vaccines.
Under the agreement, ARTES will take responsibility for developing high yield microbial cell lines expressing two recombinant enzymes. ARTES will also develop upstream 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.
Expanding mRNA technology
With the development of COVID-19 vaccines, mRNA technology has proven as an effective and fast platform for a new type of vaccines and 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 the pandemic subsides. The South Korean tissue bank and tissue graft specialist is therefore aiming to realize technological independence of materials through the localization of the production enzymes that are key raw materials for mRNA vaccines. Cellumed plans to supply production enzymes initially to the Korean market, subsequently expanding to global markets.
ARTES Biotechnology Managing Director Dr. Michael Piontek commented: “We are very proud to be chosen by Cellumed for this important task of supporting the establishment of most up-to-date mRNA technology in South-Korea. We will contribute our long term experience in recombinant biotechnology and will give all our outstanding expertise and know-how in this collaboration. We are looking forward to building a strong and long lasting relation with Cellumed.”
About ARTES Biotechnology
ARTES Biotechnology is a pharmaceutical contract research & development organization that provides cell line and process development for and manufacturing of bio-pharmaceutical products.
The company is a well-established partner for many of the biggest names in the industry, with more than 20 years of business experience, a track record of products developed for and marketed by clients, as well as safe, reliable and highly competitive microbial production platforms.
ARTES specializes in recombinant cell line, process and vaccine development from microbial expression systems, marketing the unique METAVAX® (dHepB-eVLP) and SplitCore (HepBcVLP) technology in combination with yeast and E. coli expression.
ARTES operates worldwide from its 850m2 S1 facilities in Langenfeld, from where it offers cell line engineering based on yeast (Hansenula polymorpha, syn. Pichia angusta; Saccharomyces cerevisiae) and bacterial (E. coli) expression platforms, lab scale up, downstream process development, supply of non-GMP bulk material (API) for activity and toxicity tests, and technology transfer to cGMP facilities and scale-up support.
Further information at https://artes-biotechnology.biz
Cellumed is a pioneer in the field of tissue graft materials based on human-derived biomaterials, leading the localization of artificial joints and succeeding in establishing a recombinant protein production system that cultivates a large amount of growth factors for treatment. In addition, it is the foremost musculoskeletal medical device specialist in Korea, developing various products by combining excellent biotechnology and biomaterials and leading to high value-added of existing products.
Cellumed succeeded in developing and mass-producing rhBMP2, a recombinant protein derived from animal cells (CHO Cell), for the first time in Asia and for the second time in the world. In addition to rhBMP2, it has also succeeded in developing various recombinant protein growth factors such as BMP4, BMP7, GDF5, TGF-ß1, and FGF7 so that more people can lead a healthy life. Cellumed aims to become the most competitive global biotech company in the world through innovative bio product portfolios.
Learn more at: http://www.cellumed.co.kr/index2.php
Click on ARTES Biotechnology Vaccines and Biopharmaceuticals to see introductory video.