Delumping is an established operation in pharmaceutical manufacturing, used to produce more homogeneous, free-flowing powders across drug substance and drug product processes. When agglomeration is left unaddressed, it can affect powder flow, charging, homogeneity, downstream processing, cycle time and yield.
In this technical paper, Kim Geurts, Scientist PR&D and Manufacturing, Enabling Chemistry, explains how Ardena implemented in-house delumping at its Drug Substance site in Oss and what the capability has delivered in practice — from qualification using deliberately agglomerated lactose monohydrate to successful processing of highly potent OEB-5 material in a GMP client program, achieving a 98% yield.
Gain a deeper understanding of
- Why controlled delumping can improve powder flow, homogeneity and downstream process robustness without unnecessarily reducing primary particle size
- How bringing delumping in-house can reduce external dependencies, project timelines and operational risk
- How Ardena Oss has implemented and qualified a flexible, GMP-ready delumping capability for development and highly potent manufacturing programs
Subject Matter Experts
Kim Geurts
Scientist · Process Research & Development
Kim Geurts is a Scientist in Process Research & Development within Ardena’s Enabling Chemistry team in Oss. With six years of experience at Ardena, she focuses on developing and optimizing chemical processes and translating early-stage research into robust, scalable processes suitable for further development and manufacturing. Her work combines a strong foundation in chemistry with a practical understanding of process development and continuous improvement. In 2025, Kim obtained her Lean Green Belt, enabling her to complement her scientific responsibilities with the leadership of improvement initiatives across the organization. This perspective helps her identify opportunities to strengthen both technical processes and ways of working. Through this combination of scientific expertise and process-focused thinking, Kim contributes to building efficient and reliable development pathways as projects progress toward scale-up and manufacturing. She holds a Master’s degree in Chemistry from Radboud University in Nijmegen, completed in 2020. Recent Publications The Strategic Value of In-House Delumping for Homogeneous API Production.
