Innovating Contamination Control in Cell Therapy

ThermoFisher works with scientists in the biopharmaceutical field to tackle prominent issues in cell therapy. George Prout, Field Application Scientist at Thermo Fisher explained that Thermo Fisher has designed a tool that can be used for both allogenic and autologous cell therapies. The OpTmizer 1 offers a novel, single-part solution, developed using advanced omics technologies for improved performance and reduced contamination risks. Prout said: “In terms of robustness and reducing contamination risk here, this is our first true animal origin free cell therapy media.” Therefore this is a major advantage from a regulatory perspective. DynaCellect is one of Thermo Fisher’s technologies that applies to the cell therapy portfolio. It is appropriate for scaling out to have consistency, robustness, and processing speed while trying to reduce the risk of contamination. From Prout’s standpoint, cell therapy manufacturing is the biggest challenge in the supply chain. Therefore, Thermo Fisher aims to close the system and make it easier to move more samples around and fit into different workflows and DynaCellect caters to this need for flexibility. Prout added: “If you needed to pivot inside your business, move autologous to allogeneic or allogenic to autologous, there are options there with the same pieces of equipment, but then also as you scale up with different volumes as well.” It is also user-friendly and hands-off, freeing up scientists’ time to complete other tasks. The equipment relies on an automated magnetic separation system which isolates the desired cell population. Other Thermo Fisher applications such as the Dynabeads and DynaMag assist with isolating cell populations and can operate at scale. Suzy Brown, Senior Field Application Specialist at Thermo Fisher explored how scientists can reduce contamination risk by implementing Thermo Fisher’s rapid solutions for sterility testing and mycoplasma. When manufacturing cell-based therapies it is critical to decide which analytical assays to implement to facilitate this process. Brown explained that cell therapies require extensive characterization and testing to support their commercialization, this includes contaminant testing such as mycoplasma testing, and impurity testing for process-related residuals. She proposed a mycoplasma detection solution MycoSEQ and SteriSEQ as solutions. MycoSEQ is a rapid, PCR-based solution that replaces traditional 28-day culture tests with a 5-hour workflow. Moreover, it meets regulatory expectations for sensitivity and specificity, detecting over 200 mycoplasma species without cross-reactivity. SteriSEQ is a multiplex PCR assay that simultaneously detects bacterial and fungal contaminants within 5 hours. It is designed for in-process and final release testing, aligning with regulatory shifts toward risk-based contamination control strategies. Thermo Fisher Scientific's advanced media, equipment, and analytical tools address critical challenges in cell therapy manufacturing. Overall, these innovations are designed to future-proof workflows, supporting both autologous and allogeneic therapies. Finally, these tools facilitated the transition between clinical and commercial stages.