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| Cell therapies require specialized distribution strategies to safeguard sensitive materials and can be complicated by varying regulations for global shipments. Ensuring the product is delivered on time and within temperature specifications to the hospital is critical and requires meticulous planning across multiple teams. Read the case study and examine how Marken ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy from the U.S. to a manufacturing site in Germany. |
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By Erin Harris, editor-in-chief, Cell & Gene | In case you missed it, our recent Cell & Gene Live, 2024 Regulatory Outlook with FDA’s Dr. Peter Marks and Dr. Nicole Verdun, is available on demand. Here's a summary of the event. |
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| Making The Allogeneic Commercialization Journey | Article | FUJIFILM Diosynth Biotechnologies | Review the pivotal moments, challenges, triumphs, and lessons learned that have shaped an evolution from facility construction to a fully operational patient-focused CDMO. |
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| As the patient’s immune cells are the starting materials, inherent biological variability leads to CAR-T manufacturing. Additional critical raw materials also have batch-to-batch variability, which means the entire production process is a constant balancing act of adjusting the manufacturing process to create standardized manufacturing. Join Cell & Gene Live for a discussion on practical ways to overcome the challenges associated with batch-to-batch variation. Registration is free thanks to the support of Entegris. |
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