Hajer Hussein, MLER, CSW’s Post

You do not want to find out that your Word & PDFs look like this right before your submission needs to go out..... This image always makes me chuckle. Probably because it is so true. Document formatting is not an easy task. Especially when there are hundreds or thousands of documents; strict regulations on how these documents need to look like; time-constraint; last minute changes and typically lots of decentralized processes. How do you then move away from the traditional document formatting? The "we have always done it this way" method. Director regulatory operations, Sam A. and myself are going to answer this exact question in this session. Sam will take us through a real life experience of what her job looked like before and after the introduction of DocShifter at Vericel, a leading advanced cell therapy biotech company. Looking forward to seeing you there: https://lnkd.in/emwEDA7t

Let the cells thrive: the next generation of cell expansion     Committing to an unsuitable manufacturing technology early in #celltherapy development can result in expensive delays in late process transfers. Key steps in the #celltherapymanufacturing process, such as #cellexpansion, can benefit from modular automation, allowing for easy integration into an established or growing manufacturing process. In a new article, @Terumo Blood and Cell Technologies’ Hugo Fabre, Maura Barbisin, and Maria Knaub describe a cell expansion platform using hollow-fiber perfusion technology to provide an optimized cell culture environment for cell therapy manufacturing, from process development to clinical manufacturing. Read this article at your convenience here: https://lnkd.in/eSmK-Nex

The success of decentralized cell therapy manufacturing depends on us all. Watch this recent Phacilitate panel where we discuss the importance of tool selection, scalability, digital solutions, supply chain logistics, regulatory compliance, raw materials, equipment standardization, and innovative training methods.  https://lnkd.in/gqR3bEns  #celltherapycommunity #celltherapy 

Considerations around the scalability of automated cell therapy manufacturing Featuring Krishnendu Roy (Director, NSF Center for Cell Manufacturing Technologies and Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Institute of Technology, and starting August 1, 2023, the Bruce and Brigitt Evans Dean of Engineering at Vanderbilt University) who addresses questions of scalability, and recent progress towards the goal of non-clean room #GMP manufacturing - with integrated process control for the #celltherapy field. Read this #interview to learn about key recent developments and challenges regarding automation for scale up and scale out of cell therapies.