Manufacturing autologous myoblast for regenerative medicine applications.

ABSTRACT:

Background

Autologous myoblasts have been tested in the treatment of muscle-related diseases. However, the standardization of manufacturing myoblasts is still not established. Here we report a flask and animal-free medium-based method of manufacturing clinical-grade myoblast together with establishing releasing criteria for myoblast products under Good Manufacturing Practice (GMP).

Methods

Quadriceps muscle biopsy samples were donated from three patients with myogenic ptosis. After biopsy samples were digested through enzymatic dissociation, the cells were grown in T175 flasks (passage 0) and hyperflasks (passage 1) in the animal-free SkGM^TM-2 skeletal muscle cell growth medium containing 5% human platelet lysate for 15-17 days. The harvested cells were released b

SUBMITTER: Lee-Wing M 

PROVIDER: S-EPMC7547920 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature