- Andris Abramenkovs, Product Management CellCelector, Sartorius, Sweden
- Alejandra Hernandez Pichardo, PhD, Field Application Specialist EMEA - Advanced, Therapies, Austria
This session will help you better understand the solutions provided by Sartorius that can be used in a cell therapy workflow, with an emphasis on the 21 CFR Part 11 software modules that can be used to simplify compliance.
Sartorius offers an extensive range of products and solutions designed to support the various workflow steps involved in stem cell therapy process development and manufacturing. For cell isolation and expansion, Sartorius provides specialized cell culture media formulations and scalable bioreactor systems. Cell characterization and quality control are facilitated by cutting-edge high-throughput cytometry, imaging systems, and analytical instruments. Efficient cell harvesting and processing are achieved through automated systems, monolithic chromatography columns, and biopreservation solutions. By integrating these solutions, Sartorius enhances the efficiency, scalability, and regulatory compliance of stem cell therapy development and manufacturing.
Cell-based therapies provide promising new opportunities to treat disease and offer hope to patients in need. Bringing a new treatment to market requires innovative and compliant solutions that can accelerate progress from the lab, all the way to the patient, safely and cost effectively.
In this session, we will delve into the critical aspects of cell therapy research, process development and manufacturing.
Learn how to:
- Prove the robustness of your science
- Scale up production volumes
- Maintain comprehensive and precise electronic records
- Streamline regulatory submissions
- Smooth the transition from R&D to manufacturing