Data science tools and applications on the way to Pharma 4.0

V Steinwandter, D Borchert, C Herwig - Drug discovery today, 2019 - Elsevier
Highlights•Challenges the biopharmaceutical industry is facing at the moment.•Summary of
data science challenges due to biopharma particularities.•Review of today's data science …

[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 …

Model‐based design and control of a small‐scale integrated continuous end‐to‐end mAb platform

J Gomis‐Fons, H Schwarz, L Zhang… - Biotechnology …, 2020 - Wiley Online Library
A continuous integrated bioprocess available from the earliest stages of process
development allows for an easier, more efficient and faster development and …

[HTML][HTML] Optimization study on periodic counter-current chromatography integrated in a monoclonal antibody downstream process

J Gomis-Fons, N Andersson, B Nilsson - Journal of chromatography A, 2020 - Elsevier
An optimization study of an integrated periodic counter-current chromatography (PCC)
process in a monoclonal antibody (mAb) downstream process at lab scale, is presented in …

Real‐time monitoring and model‐based prediction of purity and quantity during a chromatographic capture of fibroblast growth factor 2

DG Sauer, M Melcher, M Mosor… - Biotechnology and …, 2019 - Wiley Online Library
Process analytical technology combines understanding and control of the process with real‐
time monitoring of critical quality and performance attributes. The goal is to ensure the …

An integrated continuous downstream process with real‐time control: A case study with periodic countercurrent chromatography and continuous virus inactivation

A Löfgren, J Gomis‐Fons, N Andersson… - Biotechnology and …, 2021 - Wiley Online Library
Integrated continuous downstream processes with process analytical technology offer a
promising opportunity to reduce production costs and increase process flexibility and …

Real‐time detection of mAb aggregates in an integrated downstream process

MN São Pedro, M Isaksson… - Biotechnology and …, 2023 - Wiley Online Library
The implementation of continuous processing in the biopharmaceutical industry is hindered
by the scarcity of process analytical technologies (PAT). To monitor and control a continuous …

Continuous purification of an enveloped and non-enveloped viral particle using an aqueous two-phase system

DG Turpeinen, PU Joshi, SA Kriz, S Kaur… - Separation and …, 2021 - Elsevier
Meeting the increasing demand for vaccines throughout the world is key to decrease the
spread of infectious diseases. The switch to a fully continuous vaccine manufacturing …

[HTML][HTML] Optimal loading flow rate trajectory in monoclonal antibody capture chromatography

J Gomis-Fons, M Yamanee-Nolin, N Andersson… - … of Chromatography A, 2021 - Elsevier
In this paper, we determined the optimal flow rate trajectory during the loading phase of a
mAb capture column. For this purpose, a multi-objective function was used, consisting of …

[HTML][HTML] A two-step process for capture and purification of human basic fibroblast growth factor from E. coli homogenate: Yield versus endotoxin clearance

DG Sauer, M Mosor, AC Frank, F Weiß… - Protein expression and …, 2019 - Elsevier
A two-step purification process for human basic fibroblast growth factor (FGF-2) from clarified
E. coli homogenate has been developed in which the impurity level after the second step is …