Comparative Study: Proving Performance Parity of the Gerteis Small-Scale Mill to De-Risk and Accelerate Development

Our Process and Product Development group rigorously tested the HM against the integrated mills of the Gerteis Mini-Polygran® (MPG) and Mini-Pactor® (MP) roller compactors. The study confirmed that Granule Size Distributions (GSDs) were nearly identical across all three mill types when processing both brittle and ductile formulations at various solid fractions and with different mill screen sizes.

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This proven performance parity is a significant benefit for Serán's customers. It means we can confidently:

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• Use gram-scale quantities of API to generate data that is directly representative of larger-scale processes.

• Accelerate formulation screening and process optimization, saving valuable time and resources.

• De-risk scale-up by establishing a reliable link between early-phase experiments and future manufacturing success.

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This capability underscores Serán's commitment to science-driven development, enabling us to help our partners move programs forward more efficiently and with greater confidence.

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We hope you'll enjoy reading our most recent study.

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Authors:

Vedant G Bhagali a, Hamad Haider a, Randy J Wald a* a SeránBioscience LLC, Process and Product Development, OR 97701, USA , GerteisMaschinen + Processengineering AG

Corresponding Author:

Randy J Wald

Study in collaboration with:

Gerteis Maschinen + Processengineering AG

Michael Schupp, Head of Technology & Process Engineering

Acknowledgement: The authors would like to acknowledgeGregory R. Ellis for his contributions to the initial data collection &characterization.

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