Historically, manufacturers have favored allogeneic cells derived from an external donor and have leveraged them to provide an expandable product. Allogeneic therapies might offer an initial convenience for scaling, much like a traditional biopharmaceutical,
however, because they rely on donor cells, patients might be susceptible to graft-versus-host disease.
In contrast, autologous cells, which are derived from a patient’s own cells, don’t carry that same risk. The past decade has seen a steady development of autologous therapies in clinical trials, however when it’s time to move into manufacturing, it can
be difficult to scale due to their complex manufacturing processes. Because cells are collected directly from a patient for autologous therapies, the batch size remains relatively small. Manufacturers who want to increase the scale of
autologous therapies need to scale out rather than scale up by replicating their lines or units of operation.
Automated Cell Culture Platform
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.
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