Streamlined Methods for Processing and Cryopreservation of Cell Therapy Products Using Automated Systems

Area of Science:

• Biotechnology and Biomanufacturing
• Cell Therapy Development
• Good Laboratory Practices (GLP)

Background:

• Cell therapies require robust processing and cryopreservation protocols for successful clinical translation.
• Current methods may lack standardization, impacting cell viability and product consistency.
• Good Laboratory Practices are essential for regulatory compliance and reliable biomanufacturing.

Purpose of the Study:

• To present streamlined procedures for cell therapy processing and cryopreservation applicable to both adherent and suspension cell types.
• To demonstrate the use of standard biomanufacturing equipment for high-yield cell preparation.
• To validate cell quality and phenotype post-cryopreservation.

Main Methods:

• Preparation of adherent mesenchymal stromal cells (MSCs) and suspension peripheral blood mononuclear cells (PBMCs).
• Cell processing using the Finia® Fill and Finish System and a controlled-rate freezer.
• Cryopreservation in liquid nitrogen vapor phase followed by cell phenotype and quality metric analysis.

Main Results:

• Demonstrated applicability to both adherent (MSCs) and suspension (PBMCs) cell types.
• Maintained high cell viability through controlled temperature and rapid partitioning during cryopreservation.
• Validated cell quality and phenotype post-processing and cryopreservation.

Conclusions:

• The presented protocol offers a streamlined, GLP-compliant approach for cell therapy processing and cryopreservation.
• This method ensures high cell viability and quality, crucial for biomanufacturing and clinical applications.
• The protocol is scalable for both small- and large-scale cell therapy manufacturing.