Large-scale manufacturing of allogeneic stem cell-derived NK cell therapies

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

Manufacturing of allogeneic cell therapies is complex and involves multiple challenges, above all achieving scalability without compromising product quality. Developing streamlined processes is pivotal for scale-up of manufacturing, to accommodate dosage and supply requirements, and to drive future success in product commercialization.

Attend this webinar to learn about the journey Glycostem Therapeutics has taken to develop a GMP-compliant, closed system, and feeder-free manufacturing process for the generation of allogeneic NK cell therapies: uNiK™. The process has allowed ex vivo expansion and differentiation of millions of CD34+ stem cells isolated from umbilical cord blood, in order to obtain billions of highly potent NK cells. The resulting NK cells are then ready for cryopreservation and off-the-shelf administration, and have shown promising safety and preliminary efficacy in a clinical setting.

Learn how a combination of optimized cell culture media, perfusion, process monitoring via environmental and cellular parameters, and quality control of critical product parameters enable an agile and robust manufacturing process.

• Developing an effective GMP-compliant manufacturing process for allogeneic NK cell therapies
• The importance of streamlined process development
• Scale-up strategies to maximize output
• Keys to developing rigorous product quality analysis

Monica Raimo

Senior R&D Manager at Glycostem Therapeutics

Dr. Monica Raimo leads process development activities for Glycostem’s NK cell therapies. After obtaining her PhD in Molecular Oncology from the University of Torino, she has worked in the development of RNA-based and cell-based anti-cancer therapies.

Jan Spanholtz

Chief Scientific Officer at Glycostem Therapeutics

Dr. Jan Spanholtz initiated Glycostem's research in its start-up phase in 2007 and is currently its Chief Scientific Officer (CSO). Spanholtz has over 25 years of expertise in research on stem cell biology and immunology at universities and within biotech companies. He is the author of various peer-reviewed research articles and inventor of Glycostem's proprietary technology platform to generate oNKord® from umbilical cord blood stem cells. For Glycostem, he has set up and managed several national and international collaborations and spearheaded the clinical translational efforts of Glycostem's NK-cell product, oNKord®. Jan developed the core IP strategy for Glycostem as inventor of the feeder cell-free NK-cell culture method from cord blood stem cells: a synthetic culture medium for NK-cells. He was also part of several other patent applications in the field of stem cell research.

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SPEAKERS

Monica Raimo

Senior R&D Manager at Glycostem Therapeutics

Jan Spanholtz

Chief Scientific Officer at Glycostem Therapeutics

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