DFE Pharma’s CM Platform accelerates the path from CM adoption to optimized performance
Navigate complex CM decisions with the right excipients, practical testing access and process understanding.
As pharmaceutical companies explore Continuous Manufacturing (CM), many must first determine whether their formulations and processes can perform reliably under continuous conditions. CM can integrate unit operations, support closer process monitoring and reduce intermediate handling steps associated with conventional batch production. Its implementation, however, depends on a clear understanding of how materials, formulations and process conditions interact during development.
For manufacturers considering CM, a key question is whether a specific formulation can perform consistently under continuous conditions. This requires evidence on material behavior, process interactions and potential sources of variability that may affect the state of control. Powder flow, bulk density, particle-size distribution, feeding behavior and blend uniformity can all influence process performance, depending on the equipment configuration, formulation composition and operating range.
DFE Pharma’s Continuous Manufacturing platform has been developed to support these decisions. The platform combines excipients characterized for continuous processes, access to a representative non-GMP testing environment and multidisciplinary formulation and process expertise. It is intended to support work from feasibility assessment through optimization and lifecycle management.
Material selection is one of the earliest and most important decisions in CM development. Excipients must support stable feeding, reproducible processing and robust performance over time. DFE Pharma offers an excipient portfolio characterized to support CM processes. Rather than treating an excipient as universally ‘CM-ready’, the focus is on assessing whether its material attributes and functional performance are appropriate for the intended formulation and process.
As part of the platform, DFE Pharma has added CM capabilities to its Closer to the Formulator (C2F) Center of Excellence in Hyderabad, India. The setup includes a Gericke Formulation Skid with modular feeding and blending options in a non-GMP environment. This allows formulations and process assumptions to be assessed without disrupting existing GMP manufacturing or requiring upfront infrastructure investment.
Depending on the objective, evaluations can focus on feeding performance, formulation behavior, process settings or interactions between material properties and downstream processing. The wider C2F infrastructure also provides access to pre-blending, tableting and analytical capabilities. The purpose is to generate evidence that can inform decisions on whether a formulation warrants further development, where additional investigation may be needed and how assumptions can be reduced before technology transfer or commercial production.
CM development generates complex data, but its value depends on how effectively that information is interpreted and applied. DFE Pharma’s CM platform brings together expertise in formulation development, process understanding, analytics and variability science, complemented by Gericke’s experience in continuous feeding and blending technology. This combined perspective can be applied to formulation refinement, process-window definition, variability assessment and interpretation of development data.
This approach is aligned with the lifecycle perspective described in ICH Q13, which covers the development, implementation, operation and lifecycle management of CM. In this context, regulatory readiness is closely linked to process understanding, including the rationale for material selection, operating ranges and control measures.
Pharmaceutical manufacturers exploring CM or seeking to optimize an established CM process can meet DFE Pharma’s experts at CPHI Milan 2026, booth 1A34 in Hall .1, to discuss formulation challenges, process performance and how the platform can support development decisions.
