Is innovation in automation enough to drive cell therapy manufacturing optimization?
Moving away from manual handling in large-scale cell therapy manufacturing is undisuptably the next step in optimization. Manual operations are often tricky to replicate between different operators and sites. Ensuring reproducibility is challenging and very expensive, especially in light of the lengthy training needed for GMP manufacturing. With the 20% Compound Annual Growth Rate (CAGR) of the cell and gene therapy industry, we’re likely facing a shortage of these skilled operators in the future. On top of all of this is human error- people unavoidably make mistakes.
So is automation the answer?
Several companies are currently developing automated bioreactors for cell therapy manufacturing. Previously, the approach to automation involved simply taking traditional cell culture vessels such as bottles or flasks and adding some level of automation to them – such as tubes for automated media change. Nowadays more sophisticated devices focus on improved systems that are purposely built for automation, such as cartridges or integrated valves and chambers.
This may remove the cost of manual operators, but is it enough to revolutionize the whole manufacturing process? Here’s 3 reasons why automation alone won’t cut it.
Number 1 – cells don’t care about automation
“Cells need to thrive in the culture system they are being grown in, regardless of whether this is automatic or manual”, says James Kusena, VP of Bioprocessing and Applications.
Currently, cell batches that don’t meet the quality threshold can reach up to 10% during manufacture. And that’s for commercial-stage batches that come from years of optimization. Automation won’t fix this.
Number 2 – automation is not process control
Automation allows for feedback loops but it doesn’t fix quality of measurement. “You don’t know if what you are measuring on one end reflects what is happening on the other,” explains James, “and when you try to course-correct your process, you might course-correct one end and make the other worse. This leads to very heterogeneous cell populations, the opposite of what cell therapy needs”. Once again, automation won’t fix this.
Number 3 – scientists need to be able to go up or down the ladder
Automation won’t fix the scale-down issue James explains; “While scaling up is often the focus and the ultimate goal for translating to large-scale manufacture, when scientists need to optimize the process scaling down is necessary to save on costs and allow large datasets to be gathered”. Therefore, we need bioreactors that allow scaling down and this is independent of whether they are automated or not.
Instead of focusing on automating a slightly improved version of cell culture setups, we need to start from the ground up and build sustainable systems to really revolutionize cell therapy manufacturing. At MFX, we are developing the Cyto Engine™, a microfluidics-based bioreactor where cells can thrive, be controlled precisely and, thanks to highly parallelized microfluidics, be truly scaled up and down. And yes, it is automated.