Process integration and control in continuous bioprocessing

AS Rathore, N Kateja, D Kumar - Current opinion in chemical engineering, 2018 - Elsevier
Biopharmaceutical industry is presently facing multiple economic, political and regulatory
challenges. The adoption of continuous bioprocessing is expected to partly alleviate these …

Model-assisted process development, characterization and design of continuous chromatography for antibody separation

YN Sun, WW Chen, SJ Yao, DQ Lin - Journal of Chromatography A, 2023 - Elsevier
Continuous manufacturing in monoclonal antibody production has generated increased
interest due to its consistent quality, high productivity, high equipment utilization, and low …

Data-driven and model-guided systematic framework for media development in CHO cell culture

JK Hong, DH Choi, SY Park, YR Silberberg… - Metabolic …, 2022 - Elsevier
Proposed herein is a systematic media design framework that combines multivariate
statistical approaches with in silico analysis of a genome-scale metabolic model of Chinese …

Integrated development of enzymatic DNA digestion and membrane chromatography processes for the purification of therapeutic adenoviruses

K Kawka, AN Wilton, P Madadkar, MFC Medina… - Separation and …, 2021 - Elsevier
High titer and purity levels are key requirements for virus-based cancer and gene therapy
biopharmaceuticals. However, the task of removing enough host-cell DNA from therapeutic …

Integrated continuous processing of proteins expressed as inclusion bodies: GCSF as a case study

N Kateja, H Agarwal, V Hebbi… - Biotechnology …, 2017 - Wiley Online Library
Affordability of biopharmaceuticals continues to be a challenge, particularly in developing
economies. This has fuelled advancements in manufacturing that can offer higher …

Model-based design of process strategies for cell culture bioprocesses: state of the art and new perspectives

J Möller, R Pörtner - New insights into cell culture technology, 2017 - books.google.com
Production processes for biopharmaceuticals with mammalian cells have to provide a nearly
optimal environment to promote cell growth and product formation. Design and operation of …

[图书][B] Perfusion Cell Culture Processes for Biopharmaceuticals: Process Development, Design, and Scale-up

M Wolf, JM Bielser, M Morbidelli - 2020 - books.google.com
Master the design and operation of perfusion cell cultures with this authoritative reference.
Discover the current state-of-the-art in the design and operation of continuous bioreactors …

Knowledge management in a waste based biorefinery in the QbD paradigm

AS Rathore, VR Chopda, J Gomes - Bioresource technology, 2016 - Elsevier
Shifting resource base from fossil feedstock to renewable raw materials for production of
chemical products has opened up an area of novel applications of industrial biotechnology …

Continuous downstream processing for production of biotech therapeutics

AS Rathore, N Kateja, H Agarwal - … : Innovative Technologies and …, 2017 - books.google.com
Continuous processing involves running unit operations of a process at steady state such
that production can continue for a considerable amount of time (typically in months). This is …

Development and validation of a mass spectrometric method to determine the identity of rituximab based on its microheterogeneity profile

FC Perdomo-Abúndez, L Vallejo-Castillo… - … of Chromatography B, 2020 - Elsevier
Analytical methods have been considered the “eyes” for development, characterization and
batch releasing of biotherapeutics over the past 40 years. One of the most powerful …