4.5 Article

Evaluating the impact of cell culture process parameters on monoclonal antibody N-glycosylation

期刊

JOURNAL OF BIOTECHNOLOGY
卷 188, 期 -, 页码 88-96

出版社

ELSEVIER
DOI: 10.1016/j.jbiotec.2014.08.026

关键词

Hybridoma cell culture; Glycosylation; Galactosylation; Sialylation; Fucosylation

资金

  1. Swiss National Science Foundation [200020_147137/1]
  2. Swiss National Science Foundation (SNF) [200020_147137] Funding Source: Swiss National Science Foundation (SNF)

向作者/读者索取更多资源

Bioreactor process parameters influence the N-linked glycosylation profile of the produced monoclonal antibodies. A systematic assessment of their impact is a prerequisite for providing controllability over glycosylation, one of the most critical quality attributes of therapeutic antibodies. In this study we investigated the effect of single and combined chemical and mechanical stress parameters on the glycan microheterogeneity of an IgG(1) antibody using a shift-experiment procedure in batch cultures. The N-linked glycosylation profile of the murine IgG(1) was found to be highly complex since it included terminal galactosylation and sialylation, as well as variable core-fucosylation. Within a pH range of 6.8 to 7.8 differences in galactosylation and sialylation of approximately 50% were obtained. Variation of dissolved oxygen tension (10-90% air saturation) resulted in a maximum variability of 20% in galactosylation and 30% in sialylation. In contrast, no significant effect on the glycosylation profile was observed when osmolarity increased from 320 to 420 mOsm/kg and sparging from 0.05 to 0.2 vvm. In this study a better understanding of bioprocess-related factors affecting critical quality attributes under the scope of QbD is provided and can bring us one step closer towards desired and targeted glycosylation for future therapeutic proteins. (C) 2014 Elsevier B.V. All rights reserved.

作者

我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。

评论

主要评分

4.5
评分不足

次要评分

新颖性
-
重要性
-
科学严谨性
-
评价这篇论文

推荐

Article Biotechnology & Applied Microbiology

Analysis and optimal design of batch and two-column continuous chromatographic frontal processes for monoclonal antibody purification

Ce Shi, Sebastian Vogg, Dong-Qiang Lin, Mattia Sponchioni, Massimo Morbidelli

Summary: A study developed a design procedure (DP) suitable for optimizing both batch frontal chromatography and Flow2 in terms of purity, yield, and productivity. Comparing the two operated at their optimal conditions showed that the Flow2 process demonstrated a more favorable Pareto front of yield and productivity at a specified purity, and exhibited improved robustness compared to the batch process.

BIOTECHNOLOGY AND BIOENGINEERING (2021)

Article Chemistry, Multidisciplinary

Development of a Unique Rapid Test to Detect Antibodies Directed Against an Extended RBD of SARS-CoV-2 Spike Protein

Larissa Brosi, Eric Kuebler, Anna Weston, Patrick Romann, Sherin Panikulam, Lorin Dirscherl, Michael Gerspach, Cedric Giegelmann, Daniele Dolce, Marie-Eve Ueberschlag, Anna Melone, Frank Bantleon, Thomas K. Villiger, Christian-B Gerhold

Summary: The study demonstrates the recombinant expression of an extended receptor binding domain (RBD) of the SARS-CoV-2 Spike protein for a rapid immunoassay to detect RBD binding antibodies with high sensitivity and specificity. This test can also be used to monitor a successful immune response after vaccination with an RBD based vaccine, as current vaccines target the Spike RBD.

CHIMIA (2021)

Article Engineering, Chemical

The preparation of mono- and multicomponent nanoparticle aggregates with layer-by-layer structure using emulsion templating method in microfluidics

Martina Jezkova, Petr Jelinek, Oskar Marelja, Dan Trunov, Marketa Jarosova, Zdenek Slouka, Miroslav Soos

Summary: Multicomponent hollow aggregates were prepared using an emulsion templating method adapted to microfluidic format, with IO and Au NPs in an inner inorganic shell covered with PCL NPs. Smaller aggregates were achieved compared to immiscible phases due to diffusion controlled shrinkage, with surface properties controlled by the mobilities and affinities of IO, Au, and PCL NPs. The biocompatible surface layer and inorganic shell with core space for cargo loading make these constructs advantageous for medicinal applications.

CHEMICAL ENGINEERING SCIENCE (2022)

Article Chemistry, Physical

Impact of Solvent-Drug Interactions on the Desolvation of a Pharmaceutical Solvate

Yannis Vasilopoulos, Jan Heyda, Jan Rohlicek, Eliska Skorepova, Vitek Zvonicek, Miroslav Soos

Summary: This study investigates the kinetics of desolvation in drug manufacturing, focusing on the interaction between solvents and active pharmaceutical ingredients (APIs). The results reveal the role of solvent diffusion and provide insights into the nanoscale interactions between the drug and solvent molecules during desolvation.

JOURNAL OF PHYSICAL CHEMISTRY B (2022)

Article Biotechnology & Applied Microbiology

Continuous countercurrent chromatographic twin-column purification of oligonucleotides: The role of the displacement effect

Ismaele Fioretti, Thomas Mueller-Spaeth, Richard Weldon, Sebastian Vogg, Massimo Morbidelli, Mattia Sponchioni

Summary: Oligonucleotides (ONs) are a promising class of biotherapeutics in the biopharmaceutical industry due to their unique way of regulating gene expression and influencing protein synthesis. However, their production cost limits large-scale manufacturing, which can be alleviated through process intensification. In this study, an efficient and continuous chromatographic purification process for ONs was developed, improving productivity and buffer consumption compared to traditional batch processes.

BIOTECHNOLOGY AND BIOENGINEERING (2022)

Article Chemistry, Multidisciplinary

Characterization and Insights into the Formation of New Multicomponent Solid Forms of Sofosbuvir

Argyro Chatziadi, Eliska Skorepova, Jan Jirat, Jan Rohlicek, Miroslav Soos

Summary: In this study, we successfully synthesized three cocrystals, two solvates, and two coamorphous systems of sofosbuvir using slurry experiments, solution evaporation, and mechanochemistry. We characterized these multicomponent solid forms and determined the crystal structures of sofosbuvir with piperazine, dichloromethane, and chloroform. Our results provide valuable insights into the molecular interactions in these systems.

CRYSTAL GROWTH & DESIGN (2022)

Article Pharmacology & Pharmacy

The impact of the lamination pressure on the properties of electrospinned nanofibrous films

Dominik Svara, Barbora Koprivova, Tomas Picek, Petr Mikes, Anna Kluk, Miroslav Soos

Summary: The purpose of this work is to prepare nanofibrous orally dispersible films (ODFs) using needleless electrospinning. The lamination pressure affects the mechanical properties of ODFs but has no impact on the dissolution kinetics.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2022)

Article Biochemical Research Methods

Advancing Raman model calibration for perfusion bioprocesses using spiked harvest libraries

Patrick Romann, Jakub Kolar, Daniela Tobler, Christoph Herwig, Jean-Marc Bielser, Thomas K. Villiger

Summary: This study developed a systematic Raman calibration workflow for perfusion processes in biopharmaceutical processes. The method allows for fast and specific model calibration, and can be applied to monitor other analytes of interest.

BIOTECHNOLOGY JOURNAL (2022)

Article Chemistry, Multidisciplinary

Obeticholic Acid Forms Two Series of Isostructural Non- stoichiometric Channel Solvates

Eliska Skorepova, Milos Vaclavik, Jan Jirat, Morgane Poupon, Ludeek Ridvan, Martin Babor, Miroslav Soos

Summary: The aim of this study was to investigate the solid forms of obeticholic acid and characterize their structures. Two possible solvated forms were discovered using X-ray powder diffraction, and further analysis showed that each solvate contains its respective solvent. The two series of solvates are isostructural, and single-crystal X-ray diffraction revealed that both forms are channel solvates.

CRYSTAL GROWTH & DESIGN (2022)

Article Chemistry, Multidisciplinary

Structure-property relations of a unique and systematic dataset of 19 isostructural multicomponent apremilast forms

Jan Jirat, Martin Babor, Ludek Ridvan, Eliska Skorepova, Michal Dusek, Miroslav Soos

Summary: By examining the structure-property relations of apremilast cocrystals and solvates, this study presents a unique and large dataset of multicomponent crystal forms, including previously unpublished forms. The high similarity in crystal packing among these forms makes it easier to evaluate the structure-property relations. Interestingly, a significant correlation was found between the intrinsic dissolution rate of the multicomponent forms and their solubility as well as the solubility of the guest molecules in the dissolution medium. This finding is particularly important for the design of multicomponent forms with desired properties.
Article Chemistry, Multidisciplinary

Structurally Unique Salts of Cyamemazine and Their Pharmaceutical Implications

Sreela Ramesh, Eliska Skorepova, Vaclav Eigner, Vaisakh Chelod Paingad, Vit Zvonicek, Petr Kuzel, Miroslav Soos

Summary: The aim of this study was to prepare new crystalline salts of cyamemazine, an antipsychotic drug, with dicarboxylic acids, and compare their thermal stabilities, dissolution properties, and structural features. Among the eight acids investigated, novel salts were obtained with four of them. This study provides the first-ever examination of the solid-state landscape and crystal structure of cyamemazine.

CRYSTAL GROWTH & DESIGN (2023)

Article Thermodynamics

Modelling of bubble breakage and coalescence in stirred and sparged bioreactor using the Euler-Lagrange approach

Pavel Krysa, Miroslav Soos

Summary: This study used computational fluid dynamics (CFD) to predict the breakage and coalescence of bubbles in gas-liquid systems and to predict the bubble size distribution (BSD). The CFD model was validated by comparing the simulation results with experimental data, and a characterization analysis of the system was performed.

INTERNATIONAL JOURNAL OF HEAT AND MASS TRANSFER (2022)

Article Biotechnology & Applied Microbiology

Maximizing yield of perfusion cell culture processes: Evaluation and scale-up of continuous bleed recycling

Patrick Romann, Jakub Kolar, Loic Chappuis, Christoph Herwig, Thomas K. Villiger, Jean-Marc Bielser

Summary: Bleed recycling is a novel method for increasing the yield of steady-state perfusion processes. By concentrating process bleed and selectively removing biomass, it allows for significant product saving. The use of inclined gravity settling as a bleed recycling technology showed similar efficiency to acoustic separation and had no negative impact on cell viabilities and product quality. With reduced system complexity and scalability, inclined gravity settling is the preferred technology for perfusion processes.

BIOCHEMICAL ENGINEERING JOURNAL (2023)

Article Pharmacology & Pharmacy

3D Raman mapping as an analytical tool for investigating the coatings of coated drug particles

Georgia Koutentaki, Pavel Krysa, Dan Trunov, Tomas Pekarek, Marketa Pislova, Miroslav Soos

Summary: The properties of paracetamol particles coated with carnauba wax were investigated. Raman mapping technique was used to examine the thickness and homogeneity of the coating layer. The results showed that the wax existed in two forms on the surface of the particles, and the coating thickness had high variability. The ability of carnauba wax to decrease the dissolution rate of paracetamol was confirmed.

JOURNAL OF PHARMACEUTICAL ANALYSIS (2023)

Article Biochemical Research Methods

Raman-controlled pyruvate feeding to control metabolic activity and product quality in continuous biomanufacturing

Patrick Romann, Sebastian Schneider, Daniela Tobler, Martin Jordan, Arnaud Perilleux, Jonathan Souquet, Christoph Herwig, Jean-Marc Bielser, Thomas K. Villiger

Summary: The Raman-controlled pyruvate feeding strategy stabilized metabolic activity and prevented product quality drifting in perfusion cell cultures.

BIOTECHNOLOGY JOURNAL (2023)

暂无数据