Digital twins in pharmaceutical and biopharmaceutical manufacturing: a literature review

Y Chen, O Yang, C Sampat, P Bhalode… - Processes, 2020 - mdpi.com
The development and application of emerging technologies of Industry 4.0 enable the
realization of digital twins (DT), which facilitates the transformation of the manufacturing …

The current scientific and regulatory landscape in advancing integrated continuous biopharmaceutical manufacturing

AC Fisher, MH Kamga, C Agarabi, K Brorson… - Trends in …, 2019 - cell.com
There is a trend across the pharmaceutical sector toward process intensification and
continuous manufacturing to produce small-molecule drugs or biotechnology products. For …

Process analytical technologies and data analytics for the manufacture of monoclonal antibodies

MK Maruthamuthu, SR Rudge, AM Ardekani… - Trends in …, 2020 - cell.com
Process analytical technology (PAT) for the manufacture of monoclonal antibodies (mAbs) is
defined by an integrated set of advanced and automated methods that analyze the …

Progression of continuous downstream processing of monoclonal antibodies: Current trends and challenges

B Somasundaram, K Pleitt, E Shave… - Biotechnology and …, 2018 - Wiley Online Library
Rapid advances in intensifying upstream processes for biologics production have left
downstream processing as a bottleneck in the manufacturing scheme. Biomanufacturers are …

Monoclonal antibody therapies for COVID-19: lessons learned and implications for the development of future products

B Kelley, P De Moor, K Douglas, T Renshaw… - Current Opinion in …, 2022 - Elsevier
Highlights•Multiple companies are authorized to treat COVID-19 patients with monoclonal
antibodies (mAbs).•They were discovered, developed, manufactured, tested, and approved …

[HTML][HTML] Stabilizing vaccines via drying: Quality by design considerations

Z Ghaemmaghamian, R Zarghami, G Walker… - Advanced Drug Delivery …, 2022 - Elsevier
Pandemics and epidemics are continually challenging human beings' health and imposing
major stresses on the societies particularly over the last few decades, when their frequency …

Developments and opportunities in continuous biopharmaceutical manufacturing

O Khanal, AM Lenhoff - MAbs, 2021 - Taylor & Francis
Today's biologics manufacturing practices incur high costs to the drug makers, which can
contribute to high prices for patients. Timely investment in the development and …

Process‐wide control and automation of an integrated continuous manufacturing platform for antibodies

F Feidl, S Vogg, M Wolf, M Podobnik… - Biotechnology and …, 2020 - Wiley Online Library
Integrated continuous manufacturing is entering the biopharmaceutical industry. The main
drivers range from improved economics, manufacturing flexibility, and more consistent …

Implementation of fully integrated continuous antibody processing: effects on productivity and COGm

L Arnold, K Lee, J Rucker‐Pezzini… - Biotechnology …, 2019 - Wiley Online Library
The changing landscape of the biopharmaceutical market is driving a paradigm shift toward
continuous manufacturing. To date, integrated continuous bioprocessing has not been …

A common framework for integrated and continuous biomanufacturing

J Coffman, M Brower… - Biotechnology and …, 2021 - Wiley Online Library
There is a growing application of integrated and continuous bioprocessing (ICB) for
manufacturing recombinant protein therapeutics produced from mammalian cells. At first …