Allogenic Cell Therapeutics: Successfully Creating Master Cell Banks, Working Cell Banks, And Drug Product

In all cell culturing processes, a primary cell culture is necessary to establish cell lines. When preparing these cultures, cells exist in one of two forms: anchorage-dependent or suspension cells. Anchorage-dependent primary cells require attachment to a solid support to thrive and establish adherent cultures, while suspension primary cells do not need solid support (i.e., cells are suspended in the culture media).

Often, it is assumed that suspension culture is the only viable option to achieve scale-up but, in some cases (e.g., when the primary cells are of a biological type that requires adherence), adherent scale-up is a more effective choice. Many adherent platforms exist, ranging from standard cell culture flasks to fixed-bed bioreactors, and cells often must be adapted from adherent to suspension culture. In these cases,  technologies exist to bridge an adherent cell line and a suspension bioreactor — for example, microcarrier technology, wherein the beads are suspended in culture media and act as the solid support for adherent cells, which attach to the beads. However, in the case of cell therapies, current technology is not yet ideal because the microcarriers must be removed from the final product. Still, new developments emerge daily in research labs that could be translated into improvements in a GMP environment in the future.

Waisman Biomanufacturing — whose cell therapy services include work with mesenchymal stromal cells (MSCs), human embryonic stem cell (hESC) banks, and a variety of other allogeneic cell therapy lines (e.g., lung cancer cell line) for human cell therapy applications — recently scaled up capacity at its Madison, Wisc. manufacturing facility. The company ensured its expansion focused on establishing larger scale manufacturing processes for allogeneic cell therapeutics. Waisman turned to Corning HYPERStack-36 vessels — adherent cell culture platforms that support a faster and more efficient scale-up process.