Pluripotent Stem Cell Expansion And Scale-Up

Article inspired by a Tapas and TechTalks digital event. Fast Trak Centre for Advanced Therapeutic Cell Technologies (CATCT) team members shared insights from customer collaborations.

Building on a legacy of bioprocessing

Translating a long history of biopharma knowledge to cell therapies requires industrialization (i.e., standardizing biomanufacturing workflows and equipment to manage the complexities in making and delivering cellular therapies.) Production in mammalian cells has been dominated by monoclonal antibodies (mAb) and other proteins, where cells produce the protein of interest. Information about how these cells grow is widely available, because we're typically using intensely studied and well-established cell lines.

For cell therapies, however, the cells are the product. We're tapping into new cell sources with very different and unique characteristics. We do not have a lot of the historical data to fall back on, especially when it comes to scale-up. So, upstream process development (PD) is now a major area of focus.

Upstream PD is complex for stem cell therapies, because these therapies involve many manipulations during cell differentiation or even cell engineering. Decisions made early in research will impact the entire product life cycle, so it is important to consider a good process design early on.