Quality by Design approaches to assessing the robustness of tangential flow filtration for MAb

Wee, Hyun; Koo, KeunHoe; Bae, EunJeong; Lee, TaekYeol

doi:10.1016/j.biologicals.2019.12.001

Cited by 4 publications

(3 citation statements)

References 6 publications

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“…Regarding downstream processing, the main risks can be identified from existing protein and other nucleic acid purification experiments, as the same phenomenon of gel formation and membrane fouling has been described for RNA tangential flow filtration (TFF) [68]. The choice of membrane and optimal purification buffer is specific to RNA molecules and needs to prevent phosphodiester ion formation, RNA precipitation, and denaturation [69].…”

Section: Trends Trends In Inmentioning

confidence: 99%

Quality by Design for enabling RNA platform production processes

Daniel¹,

Kis²,

Kontoravdi³

et al. 2022

Trends in Biotechnology

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Section: Trends Trends In Inmentioning

confidence: 99%

Quality by Design for enabling RNA platform production processes

Daniel¹,

Kis²,

Kontoravdi³

et al. 2022

Trends in Biotechnology

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“…The positive charge endows the filter with adsorptive capabilities, while the thick matrix offers a winding path to retain a variety of particle sizes. [21] [22] [23].When the particle load of our liquid phase was significantly larger than it was in a filtrate of 0.2 µm tangential flow filtration (TFF) procedures, the capacity of the majority of depth filters-which have huge dead volumes-was quickly depleted. It was discovered that the latter fluid could benefit from additional downstream processing.…”

Section: Centrifugation/depth Filtrationmentioning

confidence: 99%

A Review on Downstream Processing of Monoclonal Antibodies (mAbs)

Deshpande¹,

Thakur²

2022

IJRASET

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The creation of therapeutic monoclonal antibodies has increased recently. mAbs have grown significantly in relevance, and these compounds are now more crucial than ever in the global biotechnological drug industry. For the treatment of various diseases, a lot of biotechnology companies are investing in the manufacture of monoclonal antibodies. The two main processes in the synthesis of these antibodies are bioreactor production and purification. This article goes into great detail on the current purification techniques utilized for these compounds. The fundamental monoclonal antibody recovery and purification procedures, including cell harvesting, Protein A affinity chromatography, and further polishing steps, are all enumerated.

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“…Subsequently, one can perform parametric analysis to determine critical process attributes, simulating industrial processes and modifying process conditions accordingly.Because of that, the developed model can be looped into algorithms suitable for criticality analyses performance, quality attribute evaluation, and process control knowhow. By doing so, the exact design of experiment (DoE) and establishment of process operating range can be performed, which is especially important during the development stage, when it can serve as a basis for the quality-bydesign (QbD) concept, typically required in pharmaceutical and biotechnology industries during drug development(Wee et al, 2020). By modeling, critical process parameters (CPP) can be evaluated and determined within minutes without a single experiment.…”

mentioning

confidence: 99%

Designing scalable ultrafiltration/diafiltration process of monoclonal antibodies via mathematical modeling by coupling mass balances and Poisson–Boltzmann equation

Ambrožič

Arzenšek²,

Podgornik

2020

Biotech & Bioengineering

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Ultrafiltration/diafiltration (UF/DF) operations are employed for achieving the desired therapeutic monoclonal antibody (mAb) formulations. Due to electrostatic interactions between the charged proteins, solute ions, and uncharged excipients, the final pH and concentration values are not always equal to those in the DF buffer. At high protein concentrations, typical for industrial formulations, this effect becomes predominant. To account for challenges occurring in industrial environments, a robust mathematical framework enabling the prediction of pH and concentration profiles throughout the UF/DF process is provided. The proposed mechanistic model combines a macroscopic mass balance approach with a molecular approach based on a Poisson–Boltzmann equation dealing with electrostatic interactions and accounting for protein exclusion volume effect. The mathematical model was validated with experimental data of two commercially relevant mAbs obtained from an industrial UF/DF process using scalable laboratory equipment. The robustness and flexibility of the model were tested by using proteins with different isoelectric points and net charges. The latter was determined via a titration curve, enabling realistic protein charge‐pH evaluation. In addition, the model was tested for different DF buffer types containing both monovalent and polyvalent ions, with various types of uncharged excipients. The model generality enables its implementation for the UF/DF processes of other protein varieties.

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Quality by Design approaches to assessing the robustness of tangential flow filtration for MAb

Cited by 4 publications

References 6 publications

Quality by Design for enabling RNA platform production processes

Quality by Design for enabling RNA platform production processes

A Review on Downstream Processing of Monoclonal Antibodies (mAbs)

Designing scalable ultrafiltration/diafiltration process of monoclonal antibodies via mathematical modeling by coupling mass balances and Poisson–Boltzmann equation

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