Friday, May 24, 2019 Daily Archives

BioProcess International Europe 2019 Event Report

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BioProcess International Europe has distinguished itself as a must-attend event for industry decision makers around the world. While complementing and connecting to content delivered at all BPI events, this conference delivers unique and applicable information not presented anywhere else. Here, BioProcess International’s publisher and senior technical editor offer their perspectives on this year’s meeting in Vienna, Austria, with a program overview and exploration of themes that arose from the sessions and talks: from accelerated cell-line engineering to continuous bioprocessing, new…

May 24, 2019

ProBioGen licenses duck cell line tech to Vaccitech for viral vaccines

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Vaccitech has licensed the AGE1.CR duck retina cell line from ProBioGen to manufacture its viral vectored vaccines. The deal will see University of Oxford’s Jenner Institute spin-out Vaccitech gain access to ProBioGen’s technology platform based on the AGE1.CR duck retina cell line for production of its viral vectored universal flu vaccine. “We generated the AGE1.CR cell line from an embryonated Muscovy duck egg,†Ingo Jordan, director of Vaccine Strategies at ProBioGen told Bioprocess Insider. This, he explained, makes it well…

May 24, 2019

FDA issues draft guidance on biosimilar analytical studies

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The draft guidance advises industry to minimize differences between a biosimilar and its reference biologic including in the choice of expression system and manufacturing process. The US Food and Drug Administration (FDA) has been active in encouraging biosimilar development of late, publishing its long-awaited interchangeability guidance earlier this month. In its latest push the Agency has issued draft guidance entitled: ‘Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry.’ The document makes recommendations on…

May 24, 2019

Off-the-shelf CAR-T a ‘gamechanger’ for multiple myeloma, says Allogene

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Allogene expects manufacturing specifications to be a focus of IND reviews as it looks to bring an off-the-shelf CAR-T therapy for multiple myeloma through the clinic. Chimeric antigen receptor (CAR) T-cell therapies have been described as “one of the newest, emerging weapons in the fight†against multiple myeloma, a cancer affecting around 300,000 Americans every year. Some of the candidates in the clinic for multiple myeloma include Bluebird and Celgene’s BB21217, Celgene’s JCARH125 and Janssen/Legend Biotech’s LCAR-B38M, but these –…

May 24, 2019