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 …

Bioprocess control: current progress and future perspectives

AS Rathore, S Mishra, S Nikita, P Priyanka - Life, 2021 - mdpi.com
Typical bioprocess comprises of different unit operations wherein a near optimal
environment is required for cells to grow, divide, and synthesize the desired product …

Challenges in the development of soft sensors for bioprocesses: A critical review

V Brunner, M Siegl, D Geier, T Becker - Frontiers in bioengineering …, 2021 - frontiersin.org
Among the greatest challenges in soft sensor development for bioprocesses are variable
process lengths, multiple process phases, and erroneous model inputs due to sensor faults …

Recent advances in integrated process analytical techniques, modeling, and control strategies to enable continuous biomanufacturing of monoclonal antibodies

V Chopda, A Gyorgypal, O Yang… - Journal of Chemical …, 2022 - Wiley Online Library
Continuous bioprocessing is significantly changing the biological drugs (or biologics)
manufacturing landscape by potentially improving product quality, process stability, and …

Integrated continuous biomanufacturing on pilot scale for acid‐sensitive monoclonal antibodies

H Schwarz, J Gomis‐Fons, M Isaksson… - Biotechnology and …, 2022 - Wiley Online Library
In this study, we demonstrated the first, to our knowledge, integrated continuous bioprocess
(ICB) designed for the production of acid‐sensitive monoclonal antibodies, prone to …

Upstream continuous processing: recent advances in production of biopharmaceuticals and challenges in manufacturing

C Matanguihan, P Wu - Current Opinion in Biotechnology, 2022 - Elsevier
Highlights•Growing application of continuous processing in manufacturing protein
therapeutics.•Developing continuous processing for viral vector, vaccine, and cell therapy …

[HTML][HTML] Control of IgG glycosylation in CHO cell perfusion cultures by GReBA mathematical model supported by a novel targeted feed, TAFE

L Zhang, H Schwarz, M Wang, A Castan… - Metabolic …, 2021 - Elsevier
The N-linked glycosylation pattern is an important quality attribute of therapeutic
glycoproteins. It has been reported by our group and by others that different carbon sources …

[HTML][HTML] Optimization of medium with perfusion microbioreactors for high density CHO cell cultures at very low renewal rate aided by design of experiments

H Schwarz, K Lee, A Castan… - Biotechnology and …, 2023 - Wiley Online Library
A novel approach of design of experiment (DoE) is developed for the optimization of key
substrates of the culture medium, amino acids, and sugars, by utilizing perfusion …

[HTML][HTML] Continuous precipitation of antibodies by feeding of solid polyethylene glycol

MCP Royo, T De Santis, D Komuczki, P Satzer… - Separation and …, 2023 - Elsevier
The economic benefits of continuous PEG precipitation of antibodies compared to
continuous capture by protein A affinity chromatography have been always lowered by the …

[HTML][HTML] Recent advances to accelerate purification process development: A review with a focus on vaccines

D Keulen, G Geldhof, O Le Bussy, M Pabst… - … of Chromatography A, 2022 - Elsevier
The safety requirements for vaccines are extremely high since they are administered to
healthy people. For that reason, vaccine development is time-consuming and very …