[HTML][HTML] Digital transformation of the Pharmaceutical Industry: A future research agenda for management studies

M Miozza, F Brunetta, FP Appio - Technological Forecasting and Social …, 2024 - Elsevier
Despite the widespread attention given to Digital Transformation (DT), there is a notable lack
of comprehensive knowledge concerning its implications within the Pharmaceutical Industry …

What should next-generation analytical platforms for biopharmaceutical production look like?

AS Rathore, D Sarin - Trends in Biotechnology, 2024 - cell.com
Biotherapeutic products, particularly complex products such as monoclonal antibodies
(mAbs), have as many as 20–30 critical quality attributes (CQAs), thereby requiring a …

A quality by design approach in oral extended release drug delivery systems: where we are and where we are going?

AS Sousa, J Serra, C Estevens, R Costa… - Journal of …, 2023 - Springer
Background Oral extended release (ER) delivery systems have quickly gained increasing
importance because of their ability to maintain drug levels in the blood more consistently …

The transition from resin chromatography to membrane adsorbers for protein separations at industrial scale

Y Qu, I Bekard, B Hunt, J Black, L Fabri… - Separation & …, 2024 - Taylor & Francis
Membrane adsorbers (MA) are emerging as alternative unit operations in high-value protein
separation due to their many benefits, including short residence times, low pressure drop …

When bioprocess engineering meets machine learning: A survey from the perspective of automated bioprocess development

N Duong-Trung, S Born, JW Kim… - Biochemical …, 2023 - Elsevier
Abstract Machine learning (ML) is becoming increasingly crucial in many fields of
engineering but has not yet played out its full potential in bioprocess engineering. While …

Advances in bioreactor control for production of biotherapeutic products

S Nikita, S Mishra, K Gupta, V Runkana… - Biotechnology and …, 2023 - Wiley Online Library
Advanced control strategies are well established in chemical, pharmaceutical, and food
processing industries. Over the past decade, the application of these strategies is being …

[HTML][HTML] Applications of machine learning in antibody discovery, process development, manufacturing and formulation: Current trends, challenges, and opportunities

TT Khuat, R Bassett, E Otte, A Grevis-James… - Computers & Chemical …, 2024 - Elsevier
While machine learning (ML) has made significant contributions to the biopharmaceutical
field, its applications are still in the early stages in terms of providing direct support for quality …

Biochemical monitoring throughout all stages of rabies virus-like particles production by Raman spectroscopy using global models

LGO Guardalini, PE da Silva Cavalcante, J Leme… - Journal of …, 2023 - Elsevier
This work aimed to quantify growth and biochemical parameters (viable cell density, Xv; cell
viability, CV; glucose, lactate, glutamine, glutamate, ammonium, and potassium …

Smart process analytics for the end-to-end batch manufacturing of monoclonal antibodies

MS Hong, F Mohr, CD Castro, BT Smith… - Computers & Chemical …, 2023 - Elsevier
For many modern biopharmaceutical processes, manufacturers develop data-driven models
using data analytics/machine learning (DA/ML) methods. The challenge is how to select the …

Automated assembly of hybrid dynamic models for CHO cell culture processes

K Doyle, A Tsopanoglou, A Fejér, B Glennon… - Biochemical …, 2023 - Elsevier
The emergent realisation of Industry 4.0 principles across biomanufacturing, through recent
endeavours, will markedly enhance the development and manufacture of modern …