Process Development

Manufacturing Process of CAR-T Therapies

 

  • “The process is the product” - the manufacturing process of CAR-T therapies significantly influences product characteristics, and our processes are critical to production success

 

 

CAR-T

Biologics

Product

Living cells as product

Generated by cultured cells

Product Definition

Product definition continues to be refined throughout clinical studies and CMC development

Well-defined or definable

Cells Variability, Heterogeneity

Large variety of cells

Monoclonal cell lines with small variance

Source of Starting Material

Complicated process and logistics in extracting blood from patients to infusion

Cryopreserved MCB/WCB

Process

- Product-specific sequence of procedures and operations

- Little/no hold times between operations

- Little/no product purification

- Well-defined unit operations with product-specific operating parameters

- Validated hold times between unit operations common

- Extensive product purification operations

Process Scale

Scale out to meet demands

Scale up to meet demands

 

 

Zhangjiang R&D Center in Shanghai

 

  • Approximately 2,500 square meters
  • Has established an integrated cell therapy product development platform, including cell therapy process development, lentiviral vector process development , plasmids process development, sterility lab,flow cytometry assays, in vitro cell functionality assays, and molecular assays
  • Recognized as a “Foreign-invested R&D center” by Shanghai Municipal People’s Government in 2019