The role of Raman spectroscopy in biopharmaceuticals from development to manufacturing

KA Esmonde-White, M Cuellar, IR Lewis - Analytical and Bioanalytical …, 2022 - Springer
Biopharmaceuticals have revolutionized the field of medicine in the types of active
ingredient molecules and treatable indications. Adoption of Quality by Design and Process …

Modern sensor tools and techniques for monitoring, controlling, and improving cell culture processes

SJ Reyes, Y Durocher, PL Pham, O Henry - Processes, 2022 - mdpi.com
The growing biopharmaceutical industry has reached a level of maturity that allows for the
monitoring of numerous key variables for both process characterization and outcome …

Technology outlook for real‐time quality attribute and process parameter monitoring in biopharmaceutical development—A review

DP Wasalathanthri, MS Rehmann… - Biotechnology and …, 2020 - Wiley Online Library
Real‐time monitoring of bioprocesses by the integration of analytics at critical unit
operations is one of the paramount necessities for quality by design manufacturing and real …

[HTML][HTML] Monitoring of amino acids and antibody N-glycosylation in high cell density perfusion culture based on Raman spectroscopy

H Schwarz, ME Mäkinen, A Castan… - Biochemical Engineering …, 2022 - Elsevier
Raman spectrum based predictive models provide a process analytical technology (PAT)
tool for monitoring and control of culture parameters in bioprocesses. Steady-state perfusion …

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 …

Systematic assessment of process analytical technologies for biologics

C Gillespie, DP Wasalathanthri, DB Ritz… - Biotechnology and …, 2022 - Wiley Online Library
The application of process analytical technology (PAT) for biotherapeutic development and
manufacturing has been employed owing to technological, economic, and regulatory …

Current and future technologies for monitoring cultured meat: a review

D Pawar, DL Presti, S Silvestri, E Schena… - Food Research …, 2023 - Elsevier
The high population growth rate, massive animal food consumption, fast economic progress,
and limited food resources could lead to a food crisis in the future. There is a huge …

Application of Raman spectroscopy in monoclonal antibody producing continuous systems for downstream process intensification

D Yilmaz, H Mehdizadeh, D Navarro… - Biotechnology …, 2020 - Wiley Online Library
Monoclonal antibodies (mAbs) are biopharmaceuticals produced by mammalian cell lines in
bioreactors at a variety of scales. Cell engineering, media optimization, process monitoring …

Automatic real‐time calibration, assessment, and maintenance of generic Raman models for online monitoring of cell culture processes

A Tulsyan, T Wang, G Schorner… - Biotechnology and …, 2020 - Wiley Online Library
Raman spectroscopy is a multipurpose analytical technology that has found great utility in
real‐time monitoring and control of critical performance parameters of cell culture processes …

[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 …