DFE Pharma has introduced a continuous manufacturing (CM) platform designed to support formulation development, process optimization, and lifecycle management for pharmaceutical products. The initiative, developed in collaboration with Gericke, integrates excipient characterization, equipment capability, and applied expertise to enable practical evaluation of CM processes under controlled conditions.
The platform is centered at DFE Pharma’s Center of Excellence (C2F) in Hyderabad, India, and features a Gericke Formulation Skid (GFS) for modular feeding and blending. The installation operates in a non-GMP environment, allowing companies to conduct rapid formulation and process trials without interrupting commercial manufacturing or requiring upfront infrastructure investment. The setup combines the GFS with pre-blending, downstream processing, and analytical tools to generate data applicable to process design and scale-up.
DFE Pharma’s portfolio of excipients has been characterized for compatibility with continuous processing, supporting material flow consistency and enabling more stable CM operations. The company reports that this characterization helps address variability challenges that can affect blend uniformity, throughput, and overall process control during continuous production.
Through the partnership, DFE Pharma contributes expertise in formulation science, process understanding, and variability analysis, while Gericke provides engineering knowledge in continuous feeding and blending systems. The collaboration aims to give pharmaceutical developers hands-on exposure to CM operation and data interpretation, facilitating process design in line with regulatory expectations such as those outlined in ICH Q13.