Tuesday, August 6, 2019 Daily Archives

China’s GMP Strategies: Dealing with Quality Management Issues, to Compete with the West

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This webcast features: Dr. Fai Poon, President, Quacell Biotech Ltd. China’s biopharma sector faces multiple challenges in quality management, including lack of experience and talent, a rapidly changing regulatory environment, as well as cultural issues in management. In Part 3 of our series Fai Poon, President, QuaCell Biotech, Ltd., will cover China regulatory issues, a review of current challenges in biopharma quality management in China, and opportunities for progress in this field with the growing CMO platforms and the emerging…

August 6, 2019

Samsung BioLogics to make third UCB drug substance

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CDMO Samsung BioLogics will make a minimum of $70 million worth of three products for UCB from its facilities in South Korea. A spokesperson from Samsung BioLogics told this publication the extended deal with Belgium-headquarters pharma firm UCB means a third drug substance will be made by the contract development and manufacturing organization (CDMO) from its site in Songdo, Incheon. The two companies entered into a master services agreement in July 2018. The latest product to be made by Samsung…

August 6, 2019

COGS crisis: Cell therapy sector must rethink CMC says expert

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The cell therapy sector faces a cost of goods sold (COGS) crisis and needs to get beyond the “product is the process†mind-set says Anthony Davies, CEO of Dark Horse Consulting. Cell and gene therapies have attracted a lot of attention in recent years. In part this is because drugs like Yescarta, Kymriah and Zolgensma have been approved as one-off cures. However, their cost – $373,000, $475,000 and $2.1m per vial in the US, respectively – has also seen them…

August 6, 2019