Application of model-free and model-based quality-by-control (QbC) for the efficient design of pharmaceutical crystallization processes

B Szilagyi, A Eren, JL Quon… - Crystal Growth & …, 2020 - ACS Publications
The design of pharmaceutical crystallization processes is a challenging engineering
problem because of the specific and versatile quality requirements of the end-product …

Digital design of the crystallization of an active pharmaceutical ingredient using a population balance model with a novel size dependent growth rate expression. From …

B Szilagyi, A Eren, JL Quon… - Crystal Growth & …, 2021 - ACS Publications
Prediction and control of the product properties in crystallization processes are practical
challenges in the pharmaceutical industry. Effective crystallization process design and …

Experimental implementation of a Quality-by-Control (QbC) framework using a mechanistic PBM-based nonlinear model predictive control involving chord length …

B Szilágyi, Á Borsos, K Pal, ZK Nagy - Chemical Engineering Science, 2019 - Elsevier
Abstract l-ascorbic acid is synthetized in large industrial scale from glucose and marketed as
an immune system strengthening agent and anti-oxidant ingredient. The overall yield of …

Cross-pharma collaboration for the development of a simulation tool for the model-based digital design of pharmaceutical crystallization processes (CrySiV)

B Szilagyi, WL Wu, A Eren, J Mackey… - Crystal Growth & …, 2021 - ACS Publications
Precompetitive collaborations on new enabling technologies for research and development
are becoming popular among pharmaceutical companies. The Enabling Technologies …

Application of process analytical technology-based feedback control strategies to improve purity and size distribution in biopharmaceutical crystallization

E Simone, W Zhang, ZK Nagy - Crystal Growth & Design, 2015 - ACS Publications
Purity is a critical quality attribute for both pharmaceutical and biopharmaceutical products.
The presence of impurities (solvents, salts, or byproducts of the synthetic path) in drugs can …

Population balance model enabled digital design and uncertainty analysis framework for continuous crystallization of pharmaceuticals using an automated platform …

Y Barhate, H Kilari, WL Wu, ZK Nagy - Chemical Engineering Science, 2024 - Elsevier
A systematic digital design framework for the development of a digital twin of a continuous
crystallization process was presented using the model compound, diphenhydramine …

Population balance model development verification and validation of cooling crystallization of carbamazepine

YC Liu, D Acevedo, X Yang, S Naimi… - Crystal Growth & …, 2020 - ACS Publications
Using process modeling to understand process dynamics and potentially explore the design
space of a crystallization process is difficult because of its complex nature with many factors …

Optimal operation of a seeded pharmaceutical crystallization with growth-dependent dispersion

DB Patience, PC Dell'Orco… - Organic process research …, 2004 - ACS Publications
A cooling profile for a seeded pharmaceutical crystallization designed to achieve a desired
mean crystal size is found by minimizing the batch operating time subject to a crystallization …

Model-based analysis and quality-by-design framework for high aspect ratio crystals in crystallizer-wet mill systems using GPU acceleration enabled optimization

B Szilagyi, ZK Nagy - Computers & Chemical Engineering, 2019 - Elsevier
The simultaneous control of crystal size and shape is particularly important in
pharmaceutical crystallization processes. These two quantities not only influence the …

Crystal-size distribution-based dynamic process modelling, optimization, and scaling for seeded batch cooling crystallization of Active Pharmaceutical Ingredients (API …

M Trampuž, D Teslić, B Likozar - Chemical Engineering Research and …, 2021 - Elsevier
Crystallization of active pharmaceutical ingredients (API) is one of the most important and
complex multiphase engineering operations in pharmaceutical manufacturing industry. The …