In this episode of LifeSciences 360, we dive into the fascinating world of cell and gene therapy manufacturing with Carlos Yuraszeck. With over 16 years of experience, Carlos shares his deep insights into the unique challenges, opportunities, and innovations in the field, offering a detailed look into what it takes to bring life-saving therapies to patients. We cover everything from the design of manufacturing facilities to the complexities of quality systems, patient-centric innovations, and the future of allogeneic therapies.If you're interested in the life sciences, cell and gene therapy, or just curious about cutting-edge advancements in medicine, this episode is for you!Chapters:00:00 - Intro  00:02 - Understanding Cell and Gene Therapy Facilities  00:09 - Challenges in Cell Therapy Facility Design  00:26 - Automation in Manufacturing  00:42 - Balancing Quality, Cost, and Time  00:53 - Patient-Centric Manufacturing  01:21 - Guest Introduction: Carlos Yuraszeck  02:06 - Carlos’s Journey in Cell and Gene Therapy  03:21 - Unique Factors in Facility Design  04:14 - Making Facilities Operational  05:09 - Subscription Appeal  06:13 - Autologous vs. Allogeneic Cell Therapies Explained  08:13 - Adjusting Processes Based on Patient Variability  09:37 - Stem Cell Derived Therapies  10:39 - Biotech Companies: Autologous or Allogeneic?  12:07 - Strategic Decisions in Facility Design  14:50 - Phase-Appropriate Quality Systems  16:45 - Regulatory Flexibility and Urgency for Patients  18:08 - Change Control in Early vs. Late Phases  19:02 - Batch Records and Operator Judgment  20:27 - Training Focus for Different Phases  22:38 - Balancing Regulatory Requirements and Innovation  24:32 - Risk Assessment Based on Patient Needs  26:18 - The Potential of CAR T Therapies  28:05 - The Allogeneic Space and Future Prospects  31:00 - The Transformative Impact of Cell Therapy  32:22 - Carlos’s Career Lessons and Fear of the Unknown  34:45 - Closing Remarks and Subscription Reminder  36:37 - Outro---🔗 Links Mentioned:Connect with Carlos on LinkedIn: https://www.linkedin.com/in/carlos-yuraszeck-5400091/- Follow Life Sciences 360 on LinkedIn (https://www.linkedin.com/company/life-sciences-360)--- Subscribe to our podcast for more insights on life sciences: 🍎Apple podcast: https://apple.co/3RXPoS1🟩 Spotify podcast: https://spoti.fi/3EbDZbr💬 Let us know in the comments: Did you know worms could be this powerful?  👍 Don't forget to hit Like and Subscribe for more fascinating interviews with leaders in life sciences!Make sure to subscribe for more industry insights, and don't forget to leave a comment or question for our guest, Carlos Yuraszeck!---#Celltherapy #GMPoperations #executivedirector #astellaspharma #CellTherapyManufacturing #facilitydesign #DesigningCellFor transcripts, check out the podcast website - www.lifesciencespod.com

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