Doctoral dissertation Ana Alejandra Barrera Jiménez - Increasing the applicability of Population Balance Models in the continuous pharmaceutical Twin-Screw wet granulation

Alejandra posing with the jury

BIOMATH is proud to announce that on the 26th of October, 2022, Alejandra Barrera Jiménez has succesfully defended her Doctoral Thesis!

About Alejandra:
Alejandra Barrera Jiménez obtained bachelors degree in Chemical Engineering in 2012. Subsequently, she led the implementation of biological wastewater treatment with a multidisciplinary engineering group for a private company in her native country for six years. She received her masters degree in Chemical Engineering in 2018.
graduation she started her doctoral research at BIOMATH at the faculty of Bioscience Engineering, and the Laboratory of Process Analytical Technology (LPPAT) at the Faculty of Pharmaceutical Analysis, both of which are associated with Ghent University, in Belgium. She has participated and presented her work at international conferences and authored as well as co-authored some articles published in peer-reviewed journals

Summary of the Doctoral Thesis:
The pharmaceutical industry dedicates much effort to develop products that save and prolong the lives of patients. For that reason, the industry invests considerable amounts of resources in research and development. However, due to exacting regulations and extensive stages of development, it has become more imperative than ever to target faster, more efficient and more effective drug development. A recent trend in the pharmaceutical industry is a transition from batch to continuous manufacturing.
Removing scale-up bottlenecks in the path to market can increase agility and facilitate rapid clinical development of innovative drugs. The adoption of reliable process models with adequate predictive power can expedite development stages. Is why this doctoral research focus on increase the applicability of mechanistic models such as population balance models (PBM) to future drug development in the context of continuous manufacturing. More precisely, these predictive models have been developed to predict key properties (particle size distributions and granule porosity) after wet granulation of the commercial ConsiGmaTM-25 continuous wet granulation line used for oral solid dosage manufacturing. A generic compartmental one-dimensional PBM was developed to predict the final particle size distribution starting from the material properties and process conditions (i.e., liquid-to solid ratio), this model is ready for industrial adoption. In addition, a two dimensional PBM was constructed and calibrated to predict particle size distribution and porosity.

Ghent - Belgium