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Session Details

ACROBiosystems Presentation: Overcoming Cell Therapy Manufacturing Hurdles with cutting edge GMP Solutions
Friday, September 6, 2024 10:15 AM - 10:30 AM  
Global Showcase Presentation
Presenter:
  • Anil Kumar PhD, Head of CMC in Europe, ACROBiosystems AG, Switzerland
 
Growth factors and cytokines are crucial in cell therapy manufacturing, driving cell proliferation and differentiation, which are essential for producing advanced therapeutic medicines. As MSC and iPSCs therapies and immune cell therapies, including CAR-T, NK cells, , gain prominence, there is a growing emphasis on stringent quality management across the industry.
 
With the increasing focus on manufacturing consistency and quality, rigorous quality control measures have become necessary—not only for final therapeutics but also for raw and ancillary materials. This shift requires the adoption of advanced methods and new assay validation procedures in GMP product development to ensure the safety, consistency and overall reliability of these critical materials.
 
At ACROBiosystems, we are committed to providing comprehensive solutions and high-quality GMP grade reagents essential for the clinical development of immune cell therapies, including CAR-T, NK cells, MSCs, and iPSCs. Our state-of-the-art, 20,000 square meter GMP production facility, combined with a robust GMP-grade quality management system, allows us to meet the stringent production standards required for cell therapy drugs. As a result, we have developed a range of high-quality GMP-grade ancillary products specifically designed to support the manufacturing of these advanced cell therapies.
 
Our products undergo rigorous quality management processes and adhere to drug-level release testing standards, ensuring their safety and efficacy. These GMP-grade cell therapy reagents are crafted to accelerate clinical research in immune cell therapies—including CAR-T, NK cells, MSCs, and iPSCs—ultimately facilitating faster global regulatory approvals.
 
Session Objectives:
·               Current Cell and gene therapy manufacturing workflows and bottlenecks
·               New innovative solutions towards product quality enhancement
·               Overview of Acro’s GMP production facility and capabilities
 

Anil Kumar
Head of CMC in Europe
Acrobiosystems
Speaker