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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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By Raj Bandaru, Ph.D., Associate Director, Accenture Applied Life Science Solutions | This author breaks down, summarizes, and shares detailed insight into the recent FDA draft guidance that addresses the development of drugs and biological products for rare diseases. |
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Experts on the Cell & Gene Live event, 2024 Regulatory Outlook, answer questions about pediatric development in rare diseases, diversity planning for ultra-rare disease, anticipated approvals by 2025, and more. |
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| Demystifying Custom Media Development | Article | Thermo Fisher Scientific Bioproduction | Explore four of the most common concerns surrounding custom media development and how you can avoid potential challenges and get the most from custom formulations. |
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| Analytics-Based Process Development Strategy | Application Note | 908 Devices | Understanding insect cell metabolism and amino acid content in cell media informs process development and changes in cell growth, viability, and productivity to the nutrient contents of the media. |
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| Small-Scale Aseptic Filling Technology Considerations | Article | By Josh Russell, AST | There are unique challenges involved with small-scale aseptic filling. Explore seven key considerations to guide the evaluation of small-scale aseptic filling technology and overcome these obstacles effectively. |
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| Cell Line Development For Biopharmaceutical Production | Application Note | bio-techne | With the right dispenser sorting single cells for clonal growth, you can significantly reduce time and costs, while maintaining quality and sterility in your cell line development processes. |
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| Clarification Of HEK293 Cells Using Centrifugation | Case Study | CARR Biosystems | Clarify HEK293 cells in various stages of production from research to manufacturing with a family of products that demonstrate high yield and viability rates while maintaining target NTU readings. |
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