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Cell Therapy Technologies
Scaling Cell Therapy: Bridging the Gap

Cellular therapies are getting plenty of attention these days. They hold vast potential to treat a multitude of diseases and conditions and offer the promise to revolutionize medicine. Successful commercialization of these therapies will require a way to easily and cost-effectively scale production to provide commercially relevant batch sizes, all while supporting adherence to current Good Manufacturing Practices (cGMP) and safeguarding the quality of the product. The gap between research and development, and commercialization remains wide and poses one of the biggest challenges for the industry at the moment.

Allogeneic vs. Autologous

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.

A Case for Automation

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.

Reproducibility Is Key

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.

Connect with our experts in automated cell expansion.

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