In my past I spent a great deal of time scaling up primary muscle and neuronal cell lines for gene expression studies. This requires some specialized techniques, and often some creativity, to maintain them in an undifferentiated state and to differentiate them on command. Coaxing primary lines to maintain the capability to differentiate over many passages was a challenge. I find myself wondering if the challenges seen with stem cells today, especially in scale up are similar to those that were present in growing differentiative cell lines more than 20 years ago. Do you feel that, as an industry, we are combining the lessons learned from work with differentiative cultures and large scale up of mammalian cell lines effectively?

Answer

I think the challenges you describe are definitely still there but do think significant progress has been made in the industry to address them. Cell therapies have been around for more than 20 years despite only a few being approved by the FDA and other regulatory agencies. Many lessons have been learned, especially through the regulatory processes, and there is a lot of collective experience in the industry. Unlike many other industries, there are several groups (ISCT, ARM, etc) that have formed committees to share information and strategies to address the technical as well as regulatory challenges with cell-based therapies