Genotoxic impurities in pharmaceutical manufacturing: sources, regulations, and mitigation

G Szekely, MC Amores de Sousa, M Gil… - Chemical …, 2015 - ACS Publications
Most pharmaceutical products are manufactured either by applying a total synthesis
approach or by modifying a naturally occurring product. In both cases, a wide range of …

Process intensification for pharmaceutical crystallization

J Wang, F Li, R Lakerveld - Chemical Engineering and Processing-Process …, 2018 - Elsevier
Process intensification (PI) provides great opportunities to drastically improve the
performance of chemical processes within many branches of chemical industry including the …

[HTML][HTML] Progress of pharmaceutical continuous crystallization

D Zhang, S Xu, S Du, J Wang, J Gong - Engineering, 2017 - Elsevier
Crystallization is an important unit operation in the pharmaceutical industry. At present, most
pharmaceutical crystallization processes are performed in batches. However, due to product …

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 …

API continuous cooling and antisolvent crystallization for kinetic impurity rejection in cGMP manufacturing

MD Johnson, CL Burcham, SA May… - … Process Research & …, 2021 - ACS Publications
Crystallization of 204 kg of final active pharmaceutical ingredient was accomplished
continuously using a cascade of mixed suspension mixed product removal crystallizers in …

A novel robust digital design of a network of industrial continuous cooling crystallizers of dextrose monohydrate: From laboratory experiments to industrial application

B Szilagyi, K Pal, I Beheshti Tabar… - Industrial & Engineering …, 2020 - ACS Publications
This paper presents the first-ever industrial application of the digital design of a complex,
large-scale industrial continuous crystallization network. The aim of the work is to optimize a …

Propagating input uncertainties into parameter uncertainties and model prediction uncertainties—A review

K Abdi, B Celse, K McAuley - The Canadian Journal of …, 2024 - Wiley Online Library
A review of uncertainty quantification techniques is provided for a variety of situations
involving uncertainties in model inputs (independent variables). The situations of interest are …

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 …

Polymorph Selection and Process Intensification in a Continuous Crystallization–Milling Process: A Case Study on l-Glutamic Acid Crystallized from Water

T Köllges, T Vetter - Organic Process Research & Development, 2019 - ACS Publications
The continuous crystallization of l-glutamic acid from water in a single-stage mixed-
suspension mixed-product-removal crystallizer coupled to a milling loop is studied. We show …

Membrane-assisted antisolvent crystallization: interfacial mass-transfer simulation and multistage process control

J Li, L Sheng, L Tuo, W Xiao, X Ruan… - Industrial & …, 2020 - ACS Publications
Antisolvent crystallization is an important purification technology for the pharmaceutical and
fine chemical industries. Herein, we investigated the mass-transfer mechanism of membrane …