DFE Pharma Launches Continuous Manufacturing Platform for Formulation Development
DFE Pharma announces the launch of its continuous manufacturing (CM) platform. It is designed to support pharmaceutical companies in the development, optimization, and lifecycle management of CM processes.
In collaboration with Gericke, a manufacturer of high-precision dosing, mixing, and powder processing technology, the initiative brings together CM-enabled excipients, a flexible CM test environment, and multidisciplinary expertise to enable data-driven decisions from early exploration through optimization to long-term operations.
As part of the CM platform, DFE Pharma has invested in a continuous manufacturing capability at the C2F Center of Excellence in Hyderabad, India, including a Gericke Formulation Skid (GFS). This state-of-the-art Formulation Skid with modular dosing and mixing options is located in a non-GMP environment, allowing for rapid iterations and hands-on evaluation and optimization - without disrupting existing GMP operations or having to invest in infrastructure upfront. The modular design in the C2F Center enables flexible process and formulation testing by combining the GFS with upstream, downstream, and analytical capabilities to generate decision-relevant insights. Pharmaceutical companies will have the opportunity to experience how continuous dosing and mixing work in practice, test formulation strategies with CM-enabled materials, and understand how evaluation data can be translated directly into real-world implementations.
The CM platform is based on DFE Pharma's multidisciplinary expertise in formulation development, analytics, process understanding and variability science - complemented by Gericke's specialized know-how in continuous process engineering. This combined expertise helps pharmaceutical companies accelerate learning, reduce uncertainty and implement robust development and registration strategies in line with current regulatory requirements, including the 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 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 a finished product. CM enables more consistent product quality, improved process monitoring, and potentially smaller facilities and more efficient use of resources compared to widespread batch manufacturing. Several large pharmaceutical companies have already demonstrated the benefits of CM and integrated continuous processes into parts of their production. Others are on their way - but adoption can be challenging due to high capital investment, regulatory and operational uncertainties, and the need for specialized skills and process knowledge, among other factors.
