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Demonstrates mRNA production capabilities suitable for late clinical and commercial scales.
February 24, 2022
By: Tim Wright
Editor-in-Chief, Contract Pharma
Kaneka Eurogentec, an FDA inspected contract development and manufacturing organization (CDMO), said that its mRNA manufacturing facility has successfully produced a 25-gram batch of mRNA for a U.S. customer. Eurogentec’s GMP mRNA manufacturing service offers in vitro transcription (IVT), purification, quality control and batch release of GMP material up to 25-gram scale in its current facility in Belgium. In this project Eurogentec successfully produced and purified 25 g of material in one batch that will be tested by the customer. This quantity is equivalent to 100,000’s to millions of doses of mRNA, potentially sufficient for late clinical and commercial uses. “This successful production confirms our ability to produce mRNA at large scale and with a quantity and purity level that exceeds the targets requested by the customer,” said Ingrid Dheur, vice president biopharma development, Kaneka Eurogentec. Lieven Janssens, president and CEO, Kaneka Eurogentec, said, “The rapid growth in cell and gene therapy products is driving the need for plasmid DNA and mRNA production. Our existing pharma and biotech customers have already expressed the need for such large-scale manufacturing capabilities, and we have developed methods to respond to these needs. Additionally, we are currently in the planning stages for a second manufacturing facility to further expand our GMP mRNA manufacturing offering.”
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