Emerging GMP-grade Raw Materials and Technologies for Cell Therapy: Planning for Success in Manufacturing Process Optimization

March 27th 2019 09:00 PDT; 12:00 EDT; 16:00 GMT; 17:00 CET

As more cell and gene therapies become approved for clinical use, there has been a rapid increase in the need for innovative cell manufacturing technologies that can improve product efficiency and maintain cell product integrity while meeting scale-up demands. To overcome this commercialization challenge, it is important to identify process development workflow stages where optimization is necessary, test and qualify new technologies that improve that stage of the workflow, and establish supplier relationships to secure raw materials for scale-up. Join this webinar as our expert panel discuss how to plan the successful development of new cell therapies using emerging raw materials and technologies. During the webinar the panel will explore:
  • Workflow steps where raw material optimization is needed  - where can optimization be most beneficial to your cell therapy manufacturing process?
  • The challenges of unique new raw materials and technologies in cell therapy processes
  • When should you be “GMP ready”? Regulatory considerations when using emerging raw materials and technologies
  • Scale up and production – unique raw material manufacturer supply challenges and solutions; the importance of establishing a secure raw material supply
  • As innovative cell therapies often require multiple partnerships with new raw material and technology manufacturers, should commercialization models/supplier relationships be more collaborative?
Dr Sean Kevlahan
Senior Director of Cell and Gene Therapy
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Lisa Fox
Broken Lance Biotech Consulting
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Ángel Herrero Méndez
Head of Pharmaceutical Development, Takeda Madrid – Cell Therapy Technology Center
Takeda Pharmaceuticals International Co.
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Markéta Horálková
Supply Chain Manager
Sotio a.s.
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Dr Patrick Ginty
Head of Regulatory Affairs
Cell and Gene Therapy Catapult
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