Artificial intelligence and machine learning applications in biopharmaceutical manufacturing

AS Rathore, S Nikita, G Thakur, S Mishra - Trends in Biotechnology, 2023 - cell.com
Artificial intelligence and machine learning (AI–ML) offer vast potential in optimal design,
monitoring, and control of biopharmaceutical manufacturing. The driving forces for adoption …

Integration and digitalization in the manufacturing of therapeutic proteins

H Narayanan, M Sponchioni, M Morbidelli - Chemical Engineering Science, 2022 - Elsevier
The biopharmaceutical market has experienced a tremendous growth in the last years.
However, this growth should be balanced considering the difficulty in bioproduct …

Design of biopharmaceutical formulations accelerated by machine learning

H Narayanan, F Dingfelder… - Molecular …, 2021 - ACS Publications
In addition to activity, successful biological drugs must exhibit a series of suitable
developability properties, which depend on both protein sequence and buffer composition …

[HTML][HTML] Digitization in bioprocessing: The role of soft sensors in monitoring and control of downstream processing for production of biotherapeutic products

AS Rathore, S Nikita, NG Jesubalan - Biosensors and Bioelectronics: X, 2022 - Elsevier
Owing to the advancement in the technologies, the vision of smart manufacturing is not
implausible. Development of sophisticated measuring tools, modelling approaches …

Hybrid modeling—a key enabler towards realizing digital twins in biopharma?

M Sokolov, M von Stosch, H Narayanan, F Feidl… - Current Opinion in …, 2021 - Elsevier
Digital twins (DTs) represent a vividly emerging technology in the manufacturing industry
strongly motivated by the goals of industry 4.0. It strives for smart factories with completely …

Hybrid models based on machine learning and an increasing degree of process knowledge: Application to capture chromatographic step

H Narayanan, M Luna, M Sokolov… - Industrial & …, 2021 - ACS Publications
In process engineering, two paradigms of modeling approaches exist: the mechanistic and
the data-driven approaches with the former being completely based on knowledge while the …

A novel framework of surrogate-based feasibility analysis for establishing design space of twin-column continuous chromatography

C Ding, M Ierapetritou - International Journal of Pharmaceutics, 2021 - Elsevier
Multi-column periodic counter-current chromatography (PCC) has attracted wide attention
for the primary capture for the purpose of achieving continuous biomanufacturing …

Hybrid modeling for biopharmaceutical processes: advantages, opportunities, and implementation

H Narayanan, M von Stosch, F Feidl… - Frontiers in Chemical …, 2023 - frontiersin.org
Process models are mathematical formulations (essentially a set of equations) that try to
represent the real system/process in a digital or virtual form. These are derived either based …

[HTML][HTML] Model-based optimization strategy for intensification in the chromatographic purification of oligonucleotides

ST Menza, R Prestia, I Fioretti, M Sponchioni - Journal of Chromatography A, 2024 - Elsevier
Oligonucleotides (ONs) are acquiring clinical relevance and their demand is expected to
grow. However, the ON production capacity is currently limited by high manufacturing costs …

[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 …