Scalable expansion and downstream processing of high-quality hiPSCs
This webinar demonstrates why a scalable and reproducible cell expansion process is important for translation from research to clinical manufacturing.
FUJIFILM Cellular Dynamics, Inc. (FCDI; WI, USA) is a leading developer and manufacturer of hiPSC-derived cells used in drug discovery, toxicity testing and cell therapy development with extensive experience in process optimization with various culture formats.
Here, we present microcarrier-based hiPSC 3D culture up to 10 L scale. Under optimized conditions with vertical-wheel mixing, we achieved up to 10.4 billion cell yield after 9 days while maintaining comparable cell quality, including pluripotency marker expression and viability.
In addition, closed cell washing and concentration by counterflow centrifugation was demonstrated with high viability and a recovery ratio of over 85%. Post-processed iPSCs were successfully tested in multiple downstream applications, including plating into 2D, making 3D aggregates for differentiation and cryobanking. Together, these established iPSC scale-up and processing methods allow for the routine manufacture of >10 billion iPSCs per batch.
This webinar was recorded on 29 November 2023.
What will you learn?
- Basic principles of hiPSC process development
- Pros and cons of different hiPSC culture methods
- Materials and methods for achieving a high yield of high-quality hiPSCs for use in downstream applications
- Expert tips and tricks to overcoming challenges of microcarrier-based hiPSC cell culture
Who may this interest?
- Clinical researchers developing process workflows for autologous and allogeneic cell and gene therapies
- Those expanding iPSCs for use in drug discovery, disease modeling, toxicity testing or tissue engineering
- Industry researchers in search of CDMO services for the manufacturing of hiPSC-derived cell types
Speakers
Yina Santiago-Rodriguez
Process Development Manager
FUJIFILM Cellular Dynamics, Inc. (WI, USA)
Yina Santiago-Rodriguez is a Process Development Manager at FUJIFILM Cellular Dynamics in Madison, Wisconsin. With expertise in small-scale cell culture processes, she currently leads efforts toward the development of clinical manufacturing processes, process improvement and root cause investigations for cell therapy products. Yina previously held research and process development roles within Amgen (CA, USA) and Catalent (NJ, USA), in which she drove experiments vital for commercial manufacturing operations such as characterization, validation, tech transfer and non-conformance resolution and has accumulated over 15 years in the biologics industry. Yina holds a Master’s in Biochemistry and Nutrition from the University of Puerto Rico School of Medicine (San Juan, Puerto Rico) and a Bachelor’s in Industrial Biotechnology from the University of Puerto Rico-Mayagüez (Mayagüez, Puerto Rico). Her journey showcases her dedication and leadership in the scientific community.
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