Tuesday, September 13, 2022 Daily Archives

Screen Smarter Not Harder: Expand and Accelerate Your Cell Line & Viral Vector Screening

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This webcast features: Andres Castillo, Portfolio Manager, Sartorius & Shanya Jiang, PhD, Portfolio Manager, Sartorius. Viral-based therapies like gene therapy or vaccine development require broad and thorough process screening before transitioning into optimization. Screening sets the stage to choose the best performing media, key parameters, and cell lines with minimal variability before optimizing the critical process parameters (CPPs) and critical quality attributes (CQAs). In this 15 minute webcast, Andres Castillo and Shanya Jiang, PhD from Sartorius present an automated and…

September 13, 2022

CTMC partners with Ori Bio to advance cell therapy processes

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National Resilience and MD Cancer Center joint venture CTMC will be granted precommercial access to Ori Biotech’s paperless technology platform. The Cell Therapy Manufacturing Center (CTMC) will be part of Ori’s LightSpeed Early Access Program (LEAP) as it looks to accelerate process development, commercialization, and clinical implementation of cell therapies. Both parties have outlined numerous key objectives for the collaboration. The CTMC will assess its current CAR-T processes already ongoing in its development space onto Ori’s platform to highlight technical…

September 13, 2022

Cali court’s stem cell clinic ruling ‘flawed’ and ‘dangerous,’ says CGT advocacy group

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The International Society for Cell & Gene Therapy (ISCT) has slammed the decision of a federal judge in California who ruled surgical procedure using a patients’ stem cells does not fall under the FDA’s regulatory jurisdiction. In 2017, the US Food and Drug Administration (FDA) took a series of actions “to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients.” This included the issuing of Form 483s and warning letters, the seizing of vials of materials…

September 13, 2022