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| Cell & Gene Live welcomes Dr. Peter Marks, director, CBER, FDA, and Dr. Nicole Verdun, super office director, CBER, FDA, to discuss the evolving regulatory landscape in 2024 for cell and gene therapies. Join this interactive discussion as we cover improved communication with sponsors, increased speed availability through manufacturing processes and standards development, and much more. Registration is free thanks to the support of Thermo Fisher Scientific. |
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By Shalini Nagar, Research Nester | Small interfering RNA (siRNA) is a class of molecules that play a crucial role in the regulation of gene expression. This article shares how siRNA functions as well as new market research for the field. |
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| Leverage qPCR And dPCR To Streamline Biologics Development | Article | Applied Biosystems by Thermo Fisher Scientific, qPCR | PCR methods that deliver high-quality results throughout biologics development and biomanufacturing can help biologics manufacturers bridge the gap from basic research to clinical trials and manufacturing. |
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| Optimizing And Scaling Lentiviral Vector Production | Application Note | MilliporeSigma | See how the upstream and downstream workflows of the VirusExpress platform for lentiviral vectors were optimized through the use of the design of experiments and supplementary studies. |
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| Navigating Revisions In Drug Manufacturing | Article | By Connie Leech, CAI | Explore changes made to the EU GMP Annex 1, key considerations for maintaining compliance, and statistics that underscore the consequences of non-compliance in this evolving landscape. |
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| EU GMP Annex 1: Impact On Cleaning And Disinfection | Article | By Karen Rossington, Contec, Inc. | Delve into the details of this recently rewritten guideline for preventing cross-contamination and subsequent microbial contamination of sterile medicinal products and maintaining contamination control. |
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| Improving Recovery And Quantitation Of Oligonucleotide Impurities | Application Note | By Brooke M. Koshel, Robert E. Birdsall, and Ying Qing Yu, Waters Corporation | Consider this alternative to traditional stainless-steel columns and LC systems with a non-metal flow path for UV-based oligonucleotide analysis, tackling nonspecific adsorption challenges. |
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| Executing Patient-Focused Drug Development | Article | Veristat, Inc. | The pharmaceutical industry is increasingly adopting a patient-centric approach, making the differences between individuals and diseases more crucial when crafting a clinical development program. |
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