Process analytical technologies and data analytics for the manufacture of monoclonal antibodies

MK Maruthamuthu, SR Rudge, AM Ardekani… - Trends in …, 2020 - cell.com
Process analytical technology (PAT) for the manufacture of monoclonal antibodies (mAbs) is
defined by an integrated set of advanced and automated methods that analyze the …

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 …

Recent developments in chromatographic purification of biopharmaceuticals

AS Rathore, D Kumar, N Kateja - Biotechnology letters, 2018 - Springer
Over the last several decades, researchers have time and again proposed use of non-
chromatographic methods for processing of biotherapeutic products. However …

Continuous integrated manufacturing for biopharmaceuticals: A new paradigm or an empty promise?

AS Rathore, G Thakur, N Kateja - Biotechnology and …, 2023 - Wiley Online Library
Continuous integrated bioprocessing has elicited considerable interest from the biopharma
industry for the many purported benefits it promises. Today many major biopharma …

Challenges in process control for continuous processing for production of monoclonal antibody products

AS Rathore, S Nikita, G Thakur, N Deore - Current Opinion in Chemical …, 2021 - Elsevier
Continuous processing has been garnering much interest lately for production of
biopharmaceutical products. Purported benefits include higher productivity (10-15X) …

On-line ion exchange liquid chromatography as a process analytical technology for monoclonal antibody characterization in continuous bioprocessing

BA Patel, NDS Pinto, A Gospodarek, B Kilgore… - Analytical …, 2017 - ACS Publications
Combining process analytical technology (PAT) with continuous production provides a
powerful tool to observe and control monoclonal antibody (mAb) fermentation and …

Use of HPLC as an enabler of process analytical technology in process chromatography

A Tiwari, N Kateja, S Chanana, AS Rathore - Analytical chemistry, 2018 - ACS Publications
Online monitoring of product quality attributes using high resolution analytical tools is a
prerequisite for implementation of process analytical technology (PAT) and thereby ensuring …

Quality by design (QbD)-based process development for purification of a biotherapeutic

AS Rathore - Trends in biotechnology, 2016 - cell.com
Quality by Design (QbD) is currently receiving increased attention from the pharmaceutical
community. As a result, most major biotech manufacturers are in varying stages of …

An overview of mechanistic modeling of liquid chromatography

LK Shekhawat, AS Rathore - Preparative biochemistry and …, 2019 - Taylor & Francis
Liquid chromatography is considered to be the bottleneck for purification of therapeutic
proteins. Development and optimization of chromatography process is a cumbersome …

A new flow cell and chemometric protocol for implementing in‐line Raman spectroscopy in chromatography

F Feidl, S Garbellini, S Vogg, M Sokolov… - Biotechnology …, 2019 - Wiley Online Library
On‐line monitoring tools for downstream chromatographic processing (DSP) of
biotherapeutics can enable fast actions to correct for disturbances in the upstream, gain …