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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 Joan Lau, Ph.D., Spirovant | Inhalers hold great potential for delivery of high concentrations of gene therapy directly into the lung. Review this team's experiences regarding the development of a gene therapy to treat cystic fibrosis. |
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| In Focus: The 'C' Of CDMO | Article | Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises | Delve into the intricacies of a successful CDMO relationship and learn how a collaborative approach built on shared goals and open communication can maximize the potential of your cell therapy program. |
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| Development Of A Downstream Processing Platform For AAV | Poster | By Jule Greschok and Mathias Kahl, Process Development, IDT Biologika, Magdeburg, and Dr. Thomas Kreisig, Analytical Development, IDT Biologika, Dessau | There is a growing need for innovative solutions that reduce costs while maintaining high product quality. This poster presents investigations to derive an economic and scalable method for purification of AAV. |
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| Qualification Considerations For A 'Factory-In-A-Box' | White Paper | By Moria Feighery-Ross and Wai Wong, Pharmatech Associates - A USP Company | The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive. Enter the "factory-in-a-box," which can be a game-changer. |
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