Monday, November 28, 2022 Daily Archives

Residual DNA/Protein and Mycoplasma Detection in Cell and Gene Therapy Products

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This webcast features: Hong Li, PhD, Director of Assay Transfer and Validation, WuXi Advanced Therapies. Process-related impurities such as host cell DNA and host cell proteins may have adverse effects on product quality and pose safety concerns for cell and gene therapeutic (CGT) products. These impurities must be removed to the lowest possible level in order to meet regulatory requirements, not only to ensure product safety, but also to help understand the capabilities of the manufacturing process. Therefore, throughout product…

November 28, 2022

IASO collaborates with Umoja for allogenic CAR-T therapies

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Umoja Biopharma of Seattle to test the efficacy of its iCIL off-the-shelf cell therapy platform with Shanghai IASO Bio’s CAR candidates. Umoja’s allogeneic stem cell-based cell therapy platform uses a proprietary manufacturing process to direct differentiation and expansion of iCILs, a novel class of innate lymphocytes with potent anti-tumor activity. Initially, the companies will work to develop off-the-shelf therapies for patients with acute myeloid leukemia. IASO’s lead product is an autologous BCMA CAR-T currently at NDA stage in China that…

November 28, 2022

Lack of AdComs could indicate FDA comfortable with AAV5 safety

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CSL’s recent approval and the retraction of an AdCom meeting for Biomarin may demonstrate the US FDA has become comfortable with hemophilia gene therapies and AAV5 vectors. Last week, while much of the US was preparing turkey dinners and bracing itself for family feuds, the US Food and Drug Administration (FDA) was ‘giving thanks’ to gene therapies, specifically against hemophilia. On Tuesday, CSL Behring won approval for Hemgenix (etranacogene dezaparvovec) – a single-dose therapy to treat adults with hemophilia B.…

November 28, 2022

Sartorius and Exopharm to develop large-scale exosome tech

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Sartorius BIA Separations (BIA) and Exopharm have signed a joint research agreement to address the technical challenges of large-scale exosomes for non-viral drug delivery. BIA – a chromatography firm acquired by Sartorius in October 2020 for $423 million – will use its Convective Interaction Media (CIM) monolith chromatography alongside Exopharm’s patented LEAP technology to advance large-scale therapeutic exosome production and commercialization. BIA claims its CIM monolith chromatography columns allow high-throughput, resolution separation, and capacity. Furthermore, the firm says it has…

November 28, 2022