Thursday, November 5, 2020 Daily Archives

Accelerate Cell and Gene Therapy Development and Increase Manufacturing Capacity with Higher Titer LV and AAV Transfection Platforms

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This webcast features: Leisha Kopp, Applications Scientist, Mirus Bio Cell and gene therapies show unparalleled promise to improve the human condition by eradicating cancer and rectifying genetic disorders. However, low viral titers and capacity constraints in viral vector manufacturing processes can dramatically hinder the progress of these transformative therapies. The TransIT-VirusGEN® Transfection Reagent from Mirus Bio offers a simplified, cost-effective workflow for recombinant lentivirus (LV) and adenoassociated virus (AAV) generation. TransIT-VirusGEN Transfection Reagent is also effective in both adherent and suspension HEK 293–derived…

November 5, 2020

Single-Use Technologies: Innovation and Performance

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The biotherapeutic market has been rapidly adopting single-use technologies to reduce risk and improve operational efficiencies. For more than 20 years, Thermo Fisher Scientific has pioneered single-use technologies for this industry. Our products have been proven to be robust and scalable from laboratory scale-up to current good manufacturing practice (cGMP) production applications, including single-use bioprocessing equipment, flexible containment, and rigid containment product portfolios. Our webinars will explore data, innovative products, and novel strategies featuring single-use solutions for the bioprocessing market.…

November 5, 2020

eTheRNA expands its capabilities as mRNA interest grows

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Belgium’s eTheRNA has expanded its manufacturing capabilities to serve increasing demand for mRNA material driven by COVID-19 developments. The firm has added high throughout research grade messenger RNA (mRNA) services in addition to its GMP capabilities at facilities on the Antwerp University Science Park in Niel, Belgium. The decision to add a new 400 square-meter facility was driven by an increased demand for small scale research grade mRNA material, said Bernard Saegart, VP of Manufacturing at eTheRNA, who added expansion…

November 5, 2020

Bluebird: CMC and COVID delays push sickle cell gene therapy BLA back to 2022

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Bluebird bio has asked the US FDA to take a flexible and innovative approach to the CMC comparability data review for gene therapy candidate LentiGlobin. It had been estimated that bluebird bio was aiming to submit a Biologics License Application (BLA) for its gene therapy candidate LentiGlobin (autologous CD34+ cells encoding βA-T87Q-globin gene) in the second half of 2021. But following US Food and Drug Administration (FDA) concerns, guidance has been put back by a year, management said on a…

November 5, 2020