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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 Tyler Menichiello, contributing editor | Tenaya Therapeutics' TN-201 is a clinical-stage gene therapy aimed at treating the leading cause of death in the world — heart disease. Tenaya's CEO, Faraz Ali, delves into the development of TN-201, as well as some career lessons and what he's excited about in 2024. |
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There is no guarantee that spending more money will achieve greater results. Dive into the importance of being strategic and spending your dollars wisely when investing in automation. |
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| Cell And Gene Therapy Supply Chain: Early Preparation Is Key | Article | By Matthew Farabaugh, The Center for Breakthrough Medicines | The complexity of CGT development and manufacturing is unique compared to small molecule production. Learn why supply management for CGTs requires precise planning and forecasting. |
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| Accurate Cell Culture Characterization | Application Note | By Abhinav Malhotra, Sam van Herwaarden, Mike Khor, DeeAnn Martinez-Guzman, Kris Tyner, and Matt Ball, Culture Biosciences | Achieve fast, accurate knowledge extraction from cell culture experiments, while also calculating growth rates and consumption rates and comparing variability in cell lines using a cloud native platform. |
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| Managing Outsourcing For Complex Formulations | Q&A | Ajinomoto Bio-Pharma Services | Despite the growing body of research and scientific knowledge, perhaps the biggest challenge with lipid nanoparticle-based drug formulation is the journey into the unknown. |
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| Combining Gene Therapies, Carrier Systems, And Medical Devices | Article | By Stefanie Johns, Ph.D., Kymanox Corporation | Drug delivery is one of the most significant obstacles to advancing gene therapies. Examine the opportunities for success in combining novel medical devices to improve delivery of gene therapies. |
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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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