DFE Pharma launches Continuous Manufacturing platform to accelerate and enable formulation development

DFE Pharma,  announced the launch of its Continuous Manufacturing (CM) platform, designed to support pharmaceutical companies in formulation development, optimization, and lifecycle management of CM processes. In collaboration with Gericke, a leading international company in high precision feeding, blending, and powder processing equipment, this initiative combines CM-ready excipients, flexible CM evaluation environment, and multidisciplinary expertise, enabling data-driven decisions from early exploration through optimization and long-term operation of CM.

Flexible CM testing environment

As part of the CM platform, DFE Pharma has invested in continuous manufacturing capability at its C2F Center of Excellence in Hyderabad, India, featuring a Gericke Formulation Skid (GFS).This state-of-the-art formulation skid, with modular feeding and blending options, is placed in a non-GMP environment, enabling fast iterations and practical assessment and optimization without disrupting existing GMP manufacturing or requiring upfront infrastructure investment. The modular setup at the C2F Center supports flexible process and formulations testing by combining the GFS with pre-blending and downstream process and analytical capabilities to generate decision-relevant insights. This equipment gives pharmaceutical companies the opportunity to experience how continuous feeding and blending operate in practice, test formulation strategies using CM-ready materials, and learn how evaluation data translates directly into real world implementation.

CM-ready excipients

DFE Pharma provides a differentiated portfolio of excipients characterized to perform reliably under continuous processing conditions. These excipients are fit-for-purpose to support stable processing, simplified system design, and robust lifecycle performance, helping pharmaceutical manufacturers manage material variability and meet regulatory expectations throughout development and commercialization.

Applied CM expertise

The CM platform is driven by DFE Pharma’s multidisciplinary expertise in formulation development, analytics, process understanding, and variability science, complemented by Gericke’s specialized know-how in continuous processing equipment. This combined expertise will support pharmaceutical companies to accelerate learning, reduce uncertainty, and implement robust development and registration strategies aligned with current regulatory expectations, including principles outlined in ICH Q13.

“Continuous Manufacturing is reshaping how medicines are developed and produced, but success depends on making the right choices at every stage,” said Dr. Sven Abend, Chief Executive Officer at DFE Pharma. “With our Continuous Manufacturing platform, we are bringing together our CM-ready excipients, a flexible testing environment, and applied scientific expertise. We are sure this platform will enable our customers to make informed, data-driven CM decisions from early exploration through optimization and long-term operation with confidence.”

“This platform brings together our applied expertise in formulation development, powder handling, and continuous processing science. At Gericke, we contribute decades of engineering and process knowledge, helping customers interpret CM data, understand material–equipment interactions, optimize key parameters, and align their strategies with guidelines such as ICH Q13. Together, we provide clear, science-based direction that supports a smooth transition to robust Continuous Manufacturing,” explained Markus Gericke, CEO at Gericke Group.

Continuous manufacturing is a process in which raw materials are continuously fed, transformed through controlled unit operations, and simultaneously discharged as finished product. It enables more consistent product quality, improved process control and the potential for smaller equipment footprints and more efficient use of resources compared to the more commonly used batch manufacturing. Several major pharmaceutical companies have already demonstrated the benefits of CM and integrated continuous processes into parts of their operations. Others are progressing toward CM as well, although adoption can be challenging due to high investment needs, regulatory and operational uncertainties, and the requirement for specialized skills and process understanding.

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