Hypoxic Incubation Conditions for Optimized Manufacture of Tenocyte-Based Active Pharmaceutical Ingredients of Homologous Standardized Transplant Products in Tendon Regenerative Medicine.

ABSTRACT: Human fetal progenitor tenocytes (hFPT) produced in defined cell bank systems have recently been characterized and qualified as potential therapeutic cell sources in tendon regenerative medicine. In view of further developing the manufacture processes of such cell-based active pharmaceutical ingredients (API), the effects of hypoxic in vitro culture expansion on key cellular characteristics or process parameters were evaluated. To this end, multiple aspects were comparatively assessed in normoxic incubation (i.e., 5% CO₂ and 21% O₂, standard conditions) or in hypoxic incubation (i.e., 5% CO₂ and 2% O₂, optimized conditions). Experimentally investigated parameters and endpoints included cellular proliferation, cellular morphology and size distribu

SUBMITTER: Jeannerat A 

PROVIDER: S-EPMC8616528 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature