Additional file 1: Figure S1. of GMP-conformant on-site manufacturing of a CD133+ stem cell product for cardiovascular regeneration

Schematic representation of two different logistical procedures used for the manufacturing of stem cell products in cardiovascular regenerative medicine. Manual/semi-automatic systems require centralized GMP-compliant manufacturing by an external service provider (a). Entirely closed systems such as the automatic CliniMACS Prodigy® enable decentralized GMP-compliant manufacturing by an in-house facility (b). a Centralized GMP-compliant manufacturing by an external service provider: few specialized contractors are available for a distinct cell product because standardized high-level clean rooms (Class A in B) and sophisticated training are required for the manual or semi-automatic manufacturing. This results in higher costs of the therapy due to an increased logistical effort (e.g., long-distance transportation) and longer hospitalization of the patients as well as a possible loss of cell product quality (e.g., CliniMACS® Plus). b Decentralized GMP-compliant manufacturing by an in-house facility: cell products intended for clinical application can be manufactured on-site owing to reduced clean room requirements (Class A in D) and easier standardization of processes with minimized inter-individual variability due to automatic manufacturing. Lower logistical effort (in-house transport) and shorter hospitalization enables minimized costs plus a better and stable quality of the cell product (e.g., CliniMACS Prodigy®). (PDF 109 kb)