GMP Compliant Production of a Cryopreserved Adipose-Derived Stromal Cell Product for Feasible and Allogeneic Clinical Use

Table 1

Process steps in the production of the ATIMP for allogeneic clinical application.

Processes steps	Highlights
Donor selection	Young healthy volunteer donors (male and female)
Donor serology/NAT	HIV, hepatitis B and C, syphilis, and HTLV I/II
Procurement	Water assisted liposuction
Starting material (tissue)	Lipoaspirate (abdominal subcutaneous adipose tissue)
Raw materials	Highest grade available
Isolation of SVF	Manual enzymatic digestion
Cell expansion	Closed and semi-automated
Culture conditions	Dynamic and xeno-free
Formulation (excipient)	Cryopreservation media
Quality control methods	According to product specifications
Storage	Liquid nitrogen dry storage
Stability	Storage for two years documented
Clinical use	Allogeneic application