WALTHAM, Mass. — Thermo Fisher Scientific Inc. has introduced the Gibco CTS DynaXS Single Use Bioreactor, a new cell expansion platform designed to help cell therapy developers scale manufacturing from process development through clinical production.
The Waltham, Mass.-based company said the system is intended to support flexible, cGMP-ready manufacturing for cell therapies being developed for cancer, autoimmune diseases and other conditions.
As more cell therapies move from research into clinical development and commercialization, manufacturers face growing pressure to replace static culture systems with scalable and automation-ready platforms. Those systems must support consistent quality, cost control and regulatory compliance while fitting within limited facility space and compressed development timelines.
Thermo Fisher said the CTS DynaXS Single Use Bioreactor was designed to address those needs. The stirred-tank, single-use system supports cell expansion across development and early clinical volumes, allowing developers to move from small process development batches to larger cGMP manufacturing runs.
“Cell therapy manufacturers are navigating a rapidly expanding pipeline and increasing regulatory expectations,” said Sara Henneman, vice president and general manager of Thermo Fisher Scientific’s cell culture and cell therapy business. “The CTS DynaXS bioreactor reflects our commitment to help deliver end-to-end, integrated solutions that enable customers to simplify scale-up, strengthen process control, and support the development of therapies intended for patient use.”
The company said the product expands Thermo Fisher’s Cell Therapy Systems portfolio, which supports workflows from cell isolation and activation through expansion and downstream processing. The integrated portfolio is designed to help customers build modular and scalable manufacturing strategies with unified technical support and regulatory documentation.
The cell therapy market has expanded beyond oncology into autoimmune diseases and other emerging areas, creating demand for a wider range of cell modalities and manufacturing approaches. Thermo Fisher said those applications often require different process configurations and production scales, adding complexity across development and commercialization.
“Manufacturers want platforms that grow with them,” said Andy Campbell, senior director of research and development at Thermo Fisher Scientific. “With CTS DynaXS, we are providing a solution designed specifically for cell expansion that aligns with the broader cell therapy manufacturing journey. The single-use bioreactor offers a broad operating range and flexible design, enabling customers to efficiently scale from small to large production across a wide variety of volumes, applications, and cell types.”
