Latent variable modeling to assist the implementation of Quality-by-Design paradigms in pharmaceutical development and manufacturing: A review
The introduction of the Quality-by-Design (QbD) initiative and of the Process Analytical
Technology (PAT) framework by the Food and Drug Administration has opened the route to …
Technology (PAT) framework by the Food and Drug Administration has opened the route to …
Effect of tracer material properties on the residence time distribution (RTD) of continuous powder blending operations. Part I of II: Experimental evaluation
Residence time distribution (RTD) models are essential to understand process dynamics
and support process monitoring and control in continuous manufacturing systems. RTD …
and support process monitoring and control in continuous manufacturing systems. RTD …
Enhanced understanding of pharmaceutical materials through advanced characterisation and analysis
AP Ferreira, JF Gamble, MM Leane, H Park… - Aaps Pharmscitech, 2018 - Springer
The impact of pharmaceutical materials properties on drug product quality and
manufacturability is well recognised by the industry. An ongoing effort across industry and …
manufacturability is well recognised by the industry. An ongoing effort across industry and …
Use of machine learning in prediction of granule particle size distribution and tablet tensile strength in commercial pharmaceutical manufacturing
E Mäki-Lohiluoma, N Säkkinen, M Palomäki… - International Journal of …, 2021 - Elsevier
In the manufacturing of pharmaceutical Oral Solid Dosage (OSD) forms, Particle Size
Distribution (PSD) and Tensile Strength (TS) are common in-process tests that are controlled …
Distribution (PSD) and Tensile Strength (TS) are common in-process tests that are controlled …
[HTML][HTML] Defining multivariate raw material specifications in industry 4.0
A novel methodology is proposed for defining multivariate raw material specifications
providing assurance of quality with a certain confidence level for the critical to quality …
providing assurance of quality with a certain confidence level for the critical to quality …
Adjusting plant operating conditions to widen multivariate specification regions for incoming raw materials–An optimization framework
A Paris, C Duchesne, É Poulin - Chemometrics and Intelligent Laboratory …, 2024 - Elsevier
Decision tools to determine the acceptability of an incoming lot of raw materials prior to its
purchase from a supplier is essential to ensure efficient quality control. They allow mitigating …
purchase from a supplier is essential to ensure efficient quality control. They allow mitigating …
Data analytics on raw material properties to accelerate pharmaceutical drug development
Manufacturability of active pharmaceutical ingredients (APIs) is often evaluated by an
empirical approach during development due to limited material availability. This brings …
empirical approach during development due to limited material availability. This brings …
Two novel methods to analyze the combined effect of multiple raw-materials and processing conditions on the product's final attributes: JRPLS and TPLS
S Garcia-Munoz - Chemometrics and Intelligent Laboratory Systems, 2014 - Elsevier
The challenge in the design of a new product or the troubleshooting of a manufacturing
operation is to understand how the materials, the composition of the materials and the …
operation is to understand how the materials, the composition of the materials and the …
Improving profitability of continuous processes facing raw material variability through data-driven SMB-PLS model-based adaptive control
A Paris, C Duchesne, É Poulin - Computers & Chemical Engineering, 2024 - Elsevier
Reducing the impact of lot-to-lot raw material variability through optimization of operating
conditions is key when the lots are already purchased, and available in inventory. The …
conditions is key when the lots are already purchased, and available in inventory. The …
Manifold learning and clustering for automated phase identification and alignment in data driven modeling of batch processes
CA Muñoz López, S Bhonsale, K Peeters… - Frontiers in Chemical …, 2020 - frontiersin.org
Processing data that originates from uneven, multi-phase batches is a challenge in data-
driven modeling. Training predictive and monitoring models requires the data to be in the …
driven modeling. Training predictive and monitoring models requires the data to be in the …