In a previous newsletter I stated that biotechnology in general and cell and gene therapy in particular are poised to become the breakout technologies of the 21st century,but in order to realize the full potential of the technology several deficiencies needed to be addressed. ISSCR took a big step this June by releasing Standards for Human StemCell Use in Research, a definitive guide that outlines the steps to build quality and reproducibility into stem cell research at the academic level. One of the driving forces behind increasing quality standards in stem cell research was a 2015 article¹ in PLOS Biology documenting the low reproducibility rates in preclinical life science research that resulted in a ~$28Bin lost funding due to irreproducible studies. The funding agencies, both public and private, were understandably concerned about this trend and Standards for Human Stem Cell Use in Research is an excellent example of academia coming together to address these concerns.

 But irreproducibility is just one piece of the puzzle that is commercializing stem cell science. There are two other major factors that need to be addressed, workforce development to create the skilled cadre of individuals ready to staff the positions, and physical infrastructure necessary for manufacturing.

 Let’s start with the need for manufacturing space. Covid and the transition to work from home has created a glut n the retail real estate market, space that can be repurposed into new business incubators, and phase I/II and even III manufacturing space. This will take time and capital, but it’s a problem whose solution is fairly straightforward.  

 By comparison, addressing the need for skilled workers in the biotech/cell and gene therapy space is a complex and multifaceted problem that will not be solved overnight, and the solution will be equally complex and multi-faceted, including education, training, and talent development. The BioInsights Podcast dedicated a 4-part series discussing various problems and ways to address them. Check out the link at the end of this article to see their insights.

Science, technology, engineering, and mathematics (STEM)education must be enhanced at high schools, technical colleges, and universities. This includes providing robust biology and biotechnology curricula, experimental design, and data analysis schema. Students need to not only be able to carry out the hands-on tasks but understand both how to correctly design an experiment and interpret the data. Specialized training programs that focus on biotech, cell therapy, and gene therapy, such as the Stem Cell Technologies certificated program at Madison College will need to beset up. This program, and others like it, provides practical training in the latest techniques, technologies, and regulatory frameworks.

The CultureTrax platform can be a key component in addressing these concerns in two ways. First the standardized workflows,actions with materials and standardized instructions along a timeline, removes ambiguity and speeds training. Second, the standardized workflow brings all members of the lab to the (near) same level of competency. Checkout our 2018 grant study Controlled Study Measuring the Impact of the CultureTrax Software Application on Reproducing a Stem Cell Protocol for more details.

The future of biotechnology will be transformative, touching every aspect of our lives, but we have a lot of work to do before we can realize the benefits. Standards for Human Stem Cell Use in Research addresses quality in research, and CultureTrax can help address training and workforce development for both research and manufacturing.

BioInsights Podcast

¹ FreedmanLP, Cockburn IM, Simcoe TS (2015) The Economics of Reproducibility inPreclinical Research PLoS Biol 13(6): e1002165,doi:10.1371/journal.pbio.1002165