PAT implementation for advanced process control in solid dosage manufacturing–A practical guide

S Sacher, J Poms, J Rehrl, JG Khinast - International Journal of …, 2022 - Elsevier
The implementation of continuous pharmaceutical manufacturing requires advanced control
strategies rather than traditional end product testing or an operation within a small range of …

The state of technological advancement to address challenges in the manufacture of rAAV gene therapies

F Destro, W Wu, P Srinivasan, J Joseph, V Bal… - Biotechnology …, 2024 - Elsevier
Current processes for the production of recombinant adeno-associated virus (rAAV) are
inadequate to meet the surging demand for rAAV-based gene therapies. This article reviews …

[HTML][HTML] An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US

AC Fisher, W Liu, A Schick, M Ramanadham… - International Journal of …, 2022 - Elsevier
Continuous manufacturing (CM) sends materials directly and continuously to the next step of
a process, eliminating hold times and reducing processing times. The potential benefits of …

Digital twin of a continuous direct compression line for drug product and process design using a hybrid flowsheet modelling approach

M Moreno-Benito, KT Lee, D Kaydanov… - International Journal of …, 2022 - Elsevier
The pharmaceutical industry is continuously overcoming ways to reduce its development
times to market and bring new medicines to patients with the highest quality standards …

Using residence time distribution in pharmaceutical solid dose manufacturing–A critical review

P Bhalode, H Tian, S Gupta, SM Razavi… - International journal of …, 2021 - Elsevier
While continuous manufacturing (CM) of pharmaceutical solid-based drug products has
been shown to be advantageous for improving the product quality and process efficiency in …

[HTML][HTML] An examination of process models and model risk frameworks for pharmaceutical manufacturing

T O'Connor, S Chatterjee, J Lam… - International Journal of …, 2024 - Elsevier
Process models are a growing tool for pharmaceutical manufacturing process design and
control. The Industry 4.0 paradigm promises to increase the amount of data available to …

[HTML][HTML] Powder property change after passing through a feeder: The effect of electrostatics on powder flow

Z Liu, FJ Muzzio, G Callegari - Powder Technology, 2023 - Elsevier
Powder feeding is one of the most critical processes in continuous manufacturing of powder-
related products. Predictions of final product attributes have overlooked possible changes of …

[HTML][HTML] Dynamic flowsheet model development and digital design of continuous pharmaceutical manufacturing with dissolution modeling of the final product

B Nagy, B Szilágyi, A Domokos, B Vészi, K Tacsi… - Chemical Engineering …, 2021 - Elsevier
The integration of continuous unit operations imposes a challenge on the pharmaceutical
companies aspiring to achieve plant-wide continuous manufacturing due to the additional …

Residence time distribution of continuous capture of recombinant antibody by precipitation and two stage tangential flow filtration

G Recanati, N Lali, F De Mathia… - Journal of Chemical …, 2024 - Wiley Online Library
BACKGROUND The determination of the residence time distribution of an entire process or
process step in integrated continuous biomanufacturing is required for process …

Optimal quantification of residence time distribution profiles from a quality assurance perspective

P Bhalode, SM Razavi, A Roman-Ospino… - International Journal of …, 2023 - Elsevier
Residence time distribution (RTD) has been widely applied across various fields of chemical
engineering, including pharmaceutical manufacturing, for applications such as material …