Reproducibility of GMP-compliant production of therapeutic stressed peripheral blood mononuclear cell-derived secretomes, a novel class of biological medicinal products

This study focuses on the production and evaluation of secretomes, which are substances secreted by cells that can help in tissue regeneration. Unlike traditional drugs with a single active ingredient, secretomes contain a mix of many active substances, making it challenging to ensure consistent quality and safety. The researchers produced secretomes from stressed peripheral blood mononuclear cells (PBMCs) under strict manufacturing guidelines known as Good Manufacturing Practice (GMP). They then analyzed various biological and functional properties of different batches of these secretomes to check if they were consistent and stable. The study found that the secretomes could be produced consistently under GMP, with only small differences between batches. The secretomes also remained stable for up to six months when stored at appropriate temperatures. These findings are important for developing secretomes as a new type of biological medicine for tissue regeneration.

• 1
  Inter-batch differences in the bioactive components and secretome properties were small despite considerable differences in protein concentrations and potencies between individual donor secretomes.
• 2
  Stability tests showed that the analytical and functional properties of the secretomes remained stable when lyophilisates were stored at temperatures up to + 5 °C for 6 months.
• 3
  The study demonstrated the consistent production of cell-derived, yet cell-free secretome as a biological medicinal product.