Astellas Pharma’s Approach to Cell and Gene Therapy

Life Sciences 360

In this episode of LifeSciences 360, we dive into the fascinating world of cell and gene therapy manufacturing with Carlos Yersek. 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 Yersek
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
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🔗 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)
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#Celltherapy #GMPoperations #executivedirector #astellaspharma #CellTherapyManufacturing #facilitydesign #DesigningCell

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