2025 AIChE Annual Meeting

(558f) Achieving Rapid Clinical Development and Commercialization through Dual Fill Encapsulation Technology

Authors

James Miesle - Presenter, Eli Lilly and Company
Jonathan Wade - Presenter, Eli Lilly and Company
Mark Schrad, Eli Lilly and Company
Jon Hilden, Eli Lilly and Company
Marino Gomez, Eli Lilly and Company
Carlos Monserrate, Eli Lilly and Company
Alessandro Natalini, Eli Lilly and Company
Timo Kuehnert, Harro Hoefliger
Thomas Puppich, Harro Hoefliger
Philipp Hoffmann, Harro Hoefliger
Daniel-Jakub Wilhelm, Harro Hoefliger
Lena Dietz, Harro Hoefliger
The Harro Hoefliger Modu-C MS is designed for reliable and flexible capsule production using an interchangeable trolley design. This allows for single or combination fillings on a single trolley to enable multiple powders or powder blends, pellets, tablets, mini-tablets, or active ingredients. Combinations of multiple actives or an active plus adjuvant in a single dosage form can present development challenges due to the multiplicity of dosage form presentations required, timing to develop, and material required to enable clinical trial initiation and subsequent commercialization. The work presented here highlights the successful implementation of combination filling using a drum filler and tamping pin in series to enable rapid development of a wide range of strengths with minimal material requirements, thereby accelerating the development program. Machine changes to improve process robustness and throughput during the development and commercialization process will also be highlighted, along with elements of the intended product control strategy that are enabled through on-line gravimetric monitoring and capacitance sensors.