Cell therapy manufacturing costs could be reduced dramatically using immobilized growth factors in culture according to research.

Industry interest in cell therapies has increased significantly in recent years. According to a report by US industry group PhRMA, there are 362 cell and gene therapies in clinical development, up from 289 in 2018.

The surge in cell therapies entering the clinic is the “result of years of pioneering research by America’s biopharmaceutical research companies,” according to PhRMA.

Image: iStock/Sviatlana Zyhmantovich

It also reflects the potential revenue cell therapies can generate. According to analysis by market research firm Bioinformant while prices vary, all cell therapies are expensive.

For example, cell therapies for wound care cost between $1,500 and $2,500 per administration, while those delivered via injection can cost up to $200,000 per shot. Cell-based gene therapies are valued in the $500,000 to $1 million range.

Revenue and costs

But revenue is not the only factor. The prices also reflect the high cost of goods sold (COGS) for a cell therapy according to Bioinformant.

“The cost of manufacturing a cell product cannot be compared with small molecule products manufactured by pharmaceutical companies or biomolecules produced by biotechnology companies. Cell therapies are costlier to develop, with autologous cell products commanding the highest price tags.

“In general, the manufacturing cost of autologous cell product is many times higher than that of an allogeneic product and this is reflected in the market pricing” the authors wrote.

Growth factor

Growth factors – as the name suggests – are proteins that stimulate cell growth. They are one of the most costly components of the cell therapy manufacturing process according to a 2018 study published in Frontiers in Medicine.

The authors – who looked at production strategies for allogenic therapies – said “Identifying mimetic-based alternatives to costly growth factors or leaner media alternatives would help to substantially reduce cost of goods.”

Immobilization, a step forward?

Another approach is to immobilize growth factors used in cell culture according to the team behind a study due to be published in Frontiers in Bioengineering and Biotechnology.

Author Marion Brunck, associate professor at the Monterrey Institute of Technology and Higher Education (ITESM), told Bioprocess Insider “Immobilizing growth factors is a good idea in general, as the process stabilizes the protein and prevents its degradation, internalization, i.e. bioactivity does not decrease at the same rate as with soluble proteins.

“However, some growth factors must be internalized for the transduction cascade to occur appropriately, in these situations, a different approach may be sought out, for example immobilizing the growth factor by physical entrapment which allow a gradual release in culture media.

“The take home message is that it may be a very good idea to decrease production cost but the biology of the growth factor (GF) and its signaling mechanistics must be well known.”

Brunck added that, “The impact of GF immobilization on cost will definitely vary depending on each individual process. In some cases, culture media accounts for more than half of the cost of goods, and within the cost of culture media, GF is again a big contributor.”