Cell Culture Processes for Biopharmaceutical Manufacturing

Gadgil, Mugdha

doi:10.18520/cs/v112/i07/1478-1488

Cited by 5 publications

(3 citation statements)

References 98 publications

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“…The importance of and demand for mAbs has driven research to focus on scaling up mAb production and increasing the production rate over the past 20 years. Cell line selection and engineering, chemically defined media, optimized cell culture protocols, single-use systems and the employment of 'omics databases are now well-established technologies (Farrell et al, 2014;Gadgil, 2017;Langer and Rader, 2014). Today, well-designed cell culture platforms produce up to 10 g/L of mAbs in 25,000-litre bioreactors (Butler and Meneses-Acosta, 2012;Datta et al, 2013).…”

Section: Introductionmentioning

confidence: 99%

Host cell protein removal from biopharmaceutical preparations: Towards the implementation of quality by design

Goey

Alhuthali

Kontoravdi

2018

Biotechnology Advances

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Downstream processing of protein products of mammalian cell culture currently accounts for the largest fraction of the total production cost. A major challenge is the removal of host cell proteins, which are cell-derived impurities. Host cell proteins are potentially immunogenic and can compromise product integrity during processing and hold-up steps. There is an increasing body of evidence that the type of host cell proteins present in recombinant protein preparations is a function of cell culture conditions and handling of the harvest cell culture fluid. This, in turn, can affect the performance of downstream purification steps as certain species are difficult to remove and may require bespoke process solutions. Herein, we review recent research on the interplay between upstream process conditions, host cell protein composition and their downstream removal in antibody production processes, identifying opportunities for increasing process understanding and control. We further highlight advances in analytical and computational techniques that can enable the application of quality by design.

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Section: Introductionmentioning

confidence: 99%

Host cell protein removal from biopharmaceutical preparations: Towards the implementation of quality by design

Goey

Alhuthali

Kontoravdi

2018

Biotechnology Advances

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“…( Xiao et al, 2014 ; Genzel, 2015 ; Johari et al, 2015 ; Sandig et al, 2017 ). Cell engineering approaches have also been used to obtain a desired attribute or quality in the target product produced by a cell, reduce those host cell proteins which could act as impurity and adversely impact the final product during downstream processing, or identify of an optimal site in host cell genome in order to target a transgene to that location ( Gadgil, 2017 ).…”

Section: Cell Engineering Toward Production Of Novel Antibodies For Tmentioning

confidence: 99%

Cell Line Techniques and Gene Editing Tools for Antibody Production: A Review

Dangi

Sinha²,

Dwivedi

et al. 2018

Front. Pharmacol.

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The present day modern formulation practices for drugs are based on newer tools and techniques toward effective utilization. The methods of antibody formulations are to be revolutionized based on techniques of cell engineering and gene editing. In the present review, we have discussed innovations in cell engineering toward production of novel antibodies for therapeutic applications. Moreover, this review deciphers the use of RNAi, ribozyme engineering, CRISPR-Cas-based techniques for better strategies for antibody production. Overall, this review describes the multidisciplinary aspects of the production of therapeutic proteins that has gained more attention due to its increasing demand.

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“…Before the conception of cM, cell culture technology took huge steps in several technical issues related to culture media. advances were provided in a wide range of applications: on the study of basic cell biology, cellular mechanisms, functions and interactions; characterization and testing of compounds and their toxicity in cells (verma et al, 2020); production of vaccines and biopharmaceuticals; cell engineering (Gadgil, 2017) and more. table 1 presents the historical advances concerning the development of culture media and technologies for animal cells.…”

Section: Introductionmentioning

confidence: 99%