Parexel and Health Advances Presentation: Delivering on Autoimmune Potential Will Require Significant Changes in How Cell Therapy is Delivered
Thursday, May 30, 2024 03:15 PM - 03:45 PM
Exhibit Hall - Theatre B
Global Showcase Presentation
Presenter
However, up to now this remains a very challenging endeavor, and Miltenyi Biotec is dedicated to developing technologies to address these demands. Miltenyi Biotec’s Hematopoietic Stem Cell Engineering process, facilitated by the CliniMACS Prodigy® Cell Manufacturing Platform, GMP-compliant consumables, reagents, and flow cytometric quality control solutions, can provide the necessary environment for GMP-compliant manufacturing of gene-engineered hematopoietic stem cells (HSCs).
In fact, the CliniMACS Prodigy Hematopoietic Stem Cell Engineering process automates manufacturing of gene-engineered HSCs by viral transduction of CD34+ cells.
Manufacturing takes place in sterile, single-use tubing sets connected to the CliniMACS Prodigy Instrument, providing a functionally closed system. Its robust performance reduces donor-associated variations while the flexible software allows for easy conversion of manual processes.
Session Objectives:
• Autoimmune populations present unique needs for cell therapy including expanded sites of delivery, a shifted risk-benefit profile, broader market access, and improved manufacturing efficiency.
• It is critical to ensure the cell therapy clinical development plan is designed to deliver the right data package needed to support the strongest value proposition for the target population.
- Ned Wydysh, PhD, Health Advances, United States
- Jamie Pierson, Senior Project Leader, Parexel, United States
However, up to now this remains a very challenging endeavor, and Miltenyi Biotec is dedicated to developing technologies to address these demands. Miltenyi Biotec’s Hematopoietic Stem Cell Engineering process, facilitated by the CliniMACS Prodigy® Cell Manufacturing Platform, GMP-compliant consumables, reagents, and flow cytometric quality control solutions, can provide the necessary environment for GMP-compliant manufacturing of gene-engineered hematopoietic stem cells (HSCs).
In fact, the CliniMACS Prodigy Hematopoietic Stem Cell Engineering process automates manufacturing of gene-engineered HSCs by viral transduction of CD34+ cells.
Manufacturing takes place in sterile, single-use tubing sets connected to the CliniMACS Prodigy Instrument, providing a functionally closed system. Its robust performance reduces donor-associated variations while the flexible software allows for easy conversion of manual processes.
Session Objectives:
• Autoimmune populations present unique needs for cell therapy including expanded sites of delivery, a shifted risk-benefit profile, broader market access, and improved manufacturing efficiency.
• It is critical to ensure the cell therapy clinical development plan is designed to deliver the right data package needed to support the strongest value proposition for the target population.
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