For autologous cell therapy to succeed in a larger, scaled-out setting, early adoption of an automated cell culture platform can help streamline processes and reduce obstacles to manufacturing. Planning to scale a flask-based process can be complicated and time consuming; it requires a significant investment in labor and resources and may introduce complexity and variability to the manufacturing process. An automated, closed process that replaces manual steps will make it possible for an appropriate cost of goods to be achieved, while reducing the potential for contamination due to human error. An automated cell culture platform, such as the Quantum® Cell Expansion System, makes it possible to eliminate numerous manual hands-on tasks and open events.

As cell therapy advances toward commercialization, the demand for a consistent and effective product increases. A reproducible cell culture process is necessary to meeting this demand to more efficiently produce a consistent, clinically relevant therapeutic dose. An automated cell culture platform, such as the Quantum system, allows you to lock in a reproducible cell culture process early, which can reduce revalidation efforts later. Fewer revalidations and process changes can save time and money, delivering your cellular product to market with greater speed and efficiency.

Despite the challenges of autologous cell therapy scale-out, there is little doubt of its potential for many conditions and diseases. The gap between the biology and the manufacturing will likely continue to close as automated systems, cGMP-compliant standards, and reduced process complexity begins to take hold, ultimately achieving a sustainable business model to see these groundbreaking therapies to market.