Article
Engineering, Chemical
Xing Yang, Tina Hsia, Andrea Merenda, Riyadh AL-Attabi, Ludovic F. Dumee, San H. Thang, Lingxue Kong
Summary: The purification of biopharmaceutical streams is crucial for the production of high-quality therapeutic bioproducts. In this study, a novel polyacrylonitrile (PAN)-based nanofibrous membrane with strong anion exchange functionality was developed using electrospinning. The resulting composite membranes showed positive surface charge and different surface properties due to changes in surface micro/nano morphology.
SEPARATION AND PURIFICATION TECHNOLOGY
(2022)
Article
Engineering, Chemical
Sarah Glass, Tomi Mantel, Michael Appold, Sitashree Sen, Muhammad Usman, Mathias Ernst, Volkan Filiz
Summary: Amine-functionalized PAN ultrafiltration membranes were successfully modified to enhance arsenate adsorption, showing a 5-fold increase compared to pristine PAN membranes. The modifications were confirmed using infrared spectroscopy and zeta potential measurements.
CHEMIE INGENIEUR TECHNIK
(2021)
Article
Immunology
Petra Steppert, Magdalena Mosor, Larissa Stanek, Daniel Burgstaller, Dieter Palmberger, Shirin Preinsperger, Patricia Pereira Aguilar, Matthias Mullner, Patrick Csar, Alois Jungbauer
Summary: The developed purification process efficiently captures small impurities and maintains virus infectivity through concentration and buffer exchange. The process demonstrates high flexibility and can be easily and quickly adapted to other vectors based on the measles virus vector platform.
Article
Computer Science, Interdisciplinary Applications
Federico Rischawy, Till Briskot, Nathalie Hopf, David Saleh, Gang Wang, Simon Kluters, Joey Studts, Juergen Hubbuch
Summary: Mechanistic modeling was used to describe the entire downstream process of a Fab fragment, with various models connected to predict online and offline data and accommodate input process parameter variations at large manufacturing scale.
COMPUTERS & CHEMICAL ENGINEERING
(2023)
Article
Biotechnology & Applied Microbiology
Fuminori Konoike, Masatoshi Taniguchi, Shuichi Yamamoto
Summary: A continuous downstream process for monoclonal antibodies was developed using periodic-counter current chromatography (PCCC) for capture, a batch reactor for low pH virus inactivation (VI), and flow-through chromatography (FTC) for polish. Different runs with varying feed rates and concentrations were performed, achieving good recovery and purity values. The process was found to be flexible and stable for feed fluctuations, requiring only a few surge or pool tanks in addition to the final product pool tank.
BIOTECHNOLOGY AND BIOENGINEERING
(2023)
Article
Biotechnology & Applied Microbiology
Elianet Lorenzo, Laia Miranda, Francesc Godia, Laura Cervera
Summary: Virus-like particles (VLPs) have gained interest as potential vaccines. However, the purification of VLPs is challenging due to the presence of host cell extracellular vesicles with similar characteristics. This study compared different downstream processing technologies for capturing and purifying VLPs. After implementing the best results from each step, a final VLP concentration of 1.40 x 10(10) VLPs/mL with 64% purity and 38% overall recovery was achieved. The developed purification process is suitable for scale-up of HIV-1 Gag-eGFP VLPs.
BIOTECHNOLOGY AND BIOENGINEERING
(2023)
Review
Engineering, Chemical
Xing Yang, Andrea Merenda, Riyadh AL-Attabi, Ludovic F. Dumee, Xiwang Zhang, San H. Thang, Hung Pham, Lingxue Kong
Summary: Membrane chromatography is considered a potential solution for downstream processing in protein purification. Despite limited commercial adoption in large-scale production, significant progress has been made. However, robust evaluation of its performance is still needed, and the disconnection between academic and commercial efforts should be addressed.
JOURNAL OF MEMBRANE SCIENCE
(2022)
Article
Biochemical Research Methods
Roxana Roshankhah, Kyle Jackson, Truong Thu Ngoc Nguyen, Robert Pelton, Zeinab Hosseinidoust, Raja Ghosh
Summary: As cases of multidrug resistant bacterial infections increase, scientists and clinicians are turning to bacteriophages as alternatives to antibiotics. Researchers have developed a rapid, scalable, and efficient membrane chromatographic method for purifying bacteriophages, which removes impurities and ensures a high phage count in the purified samples.
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
(2023)
Review
Biotechnology & Applied Microbiology
Joseph Lavoie, Jinxin Fan, Behnam Pourdeyhimi, Cristiana Boi, Ruben G. Carbonell
Summary: Nonwoven membranes, as highly engineered fibrous materials, can be manufactured on a large scale and modified on their surfaces using various chemistries and ligands. They have great potential for the development of novel membranes with unique properties. This article summarizes the methods of manufacturing nonwoven fabrics, reviews the use of nonwoven fabric devices in membrane chromatography, and discusses the challenges to overcome for their application in downstream processing operations.
BIOTECHNOLOGY AND BIOENGINEERING
(2023)
Article
Biotechnology & Applied Microbiology
Annabel Lyle, Christos Stamatis, Thomas Linke, Martyn Hulley, Albert Schmelzer, Richard Turner, Suzanne S. Farid
Summary: This paper introduces a decisional tool that assesses the feasibility of using non-scalable technologies at high demands for AAV manufacturing. The tool identifies optimal flowsheets that meet both cost and purity targets. The results show that switching to more scalable upstream and downstream processing alternatives is economically advantageous.
BIOTECHNOLOGY AND BIOENGINEERING
(2023)
Article
Chemistry, Multidisciplinary
Yaoming Wang, Zhengjin Yang, Liang Wu, Liang Ge, Tongwen Xu
Summary: Ion exchange membranes play a crucial role in chemical manufacturing and new applications, improving industrial efficiency and meeting environmental needs. Academician Binglin He has been the most influential figure guiding students into the field of ion exchange membranes. The most promising area for future development is alkaline stable anion-exchange membranes. Scientists driving the development of domestic ion exchange membranes have successfully transferred patented technologies for industrial use.
CHINESE JOURNAL OF CHEMISTRY
(2021)
Article
Chemistry, Physical
Aytekin Celik, Halil Hasar
Summary: The study found that polysulfone-based anion and cation exchange membranes have the lowest resistance, highest ion exchange capacities, and ionic conductivities, while polystyrene-based anion exchange and poly(butadiene-co-styrene)-based cation exchange membranes have higher tensile strengths. The chloromethylation method using a mixture of formaldehyde and HCl improved the resistance, ion exchange capacity, and ionic conductivity properties of AEMs compared to other methods.
Article
Chemistry, Physical
Boyang Zhang, Jing Liu, Wanqin Yu, Jie Gao, Xuejing Cui, Luhua Jiang
Summary: In this study, a novel core-shell structured Pt@NC/C catalyst was developed, with ultrafine Pt nanoparticles as the core and ultra-thin nitrogen-doped carbon layers as the shell. The catalyst exhibited excellent activity for the alkaline hydrogen oxidation reaction, with high mass activity and specific activity. Moreover, it showed good anti-CO poisoning ability. The interaction between Pt and the carbon layer enhanced hydroxyl adsorption, promoting reaction kinetics and improving CO resistance. This work provides a facile and feasible strategy for designing efficient and CO-resistant Pt-based catalysts.
APPLIED SURFACE SCIENCE
(2023)
Article
Biotechnology & Applied Microbiology
Daphne Keulen, Erik van der Hagen, Geoffroy Geldhof, Olivier Le Bussy, Martin Pabst, Marcel Ottens
Summary: An optimal purification process for biopharmaceutical products is crucial for meeting safety regulations and obtaining economic benefits. By employing artificial neural networks (ANNs) during global optimization, the number of flowsheets for final local optimization can be reduced, leading to a shorter overall optimization time.
BIOTECHNOLOGY AND BIOENGINEERING
(2023)
Article
Immunology
Zeyu Yang, Xingge Xu, Cristina A. T. Silva, Omar Farnos, Alina Venereo-Sanchez, Cecile Toussaint, Shantoshini Dash, Irene Gonzalez-Dominguez, Alice Bernier, Olivier Henry, Amine Kamen
Summary: Developing robust bioprocesses for pandemic influenza vaccines is crucial. A membrane chromatography-based downstream processing platform was established, achieving efficient viral recovery and reduction of host cell DNA and proteins. This method holds promise as an alternative to current industrial purification methods for influenza vaccines.
Article
Immunology
Gwendal Graenicher, Juliana Coronel, Alexander Pralow, Pavel Marichal-Gallardo, Michael Wolff, Erdmann Rapp, Alexander Karlas, Volker Sandig, Yvonne Genzel, Udo Reichl
Article
Biochemical Research Methods
Thomas Weigel, Remon Soliman, Michael W. Wolff, Udo Reichl
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
(2019)
Article
Biochemical Research Methods
Keven Lothert, Gundula Sprick, Felix Beyer, Guiliano Lauria, Peter Czermak, Michael W. Wolff
JOURNAL OF VIROLOGICAL METHODS
(2020)
Article
Biotechnology & Applied Microbiology
Jennifer J. Labisch, Franziska Bollmann, Michael W. Wolff, Karl Pflanz
Summary: Lentiviral vectors have shown great potential for gene modified cell therapy and gene therapy applications, but downstream processing remains a challenge due to the low stability of the virus. Researchers analyzed whether lentiviral vectors produced by transient transfection of HEK293 T/17 SF suspension cells can be efficiently clarified with a lab-scale method using diatomaceous earth (DE) and bioburden reducing membrane filters, achieving high recoveries. Experiment results showed that higher DE concentrations were beneficial for turbidity reduction and shorter filtration times, but with a decrease in LV titer. A DE concentration of 9 g/L was identified as a robust set-point for clarification.
JOURNAL OF BIOTECHNOLOGY
(2021)
Review
Immunology
Keven Lothert, Friederike Eilts, Michael W. Wolff
Summary: This review summarizes analytical methods for quantification of viruses or virus-like particles, grouped based on the analytical question addressed. Methods focus on the infectivity of the drug component and the quantification of viral elements through particle counting. The different techniques are compared based on advantages, drawbacks, assay time, and sample throughput.
EXPERT REVIEW OF VACCINES
(2022)
Article
Immunology
Friederike Eilts, Jennifer J. Labisch, Sabri Orbay, Yasmina M. J. Harsy, Marleen Steger, Felix Pagallies, Ralf Amann, Karl Pflanz, Michael W. Wolff
Summary: This study is based on the Orf virus as a vaccine platform and evaluates its stability in various environmental conditions. It was found that the virus remained highly infectious within a pH range of 5-7.4 and in the presence of certain buffering substances. The study also revealed the virus' low shear sensitivity induced by peristaltic pumps and mixing, as well as its sensitivity to ultrasonication.
Article
Virology
Keven Lothert, Elena Bagrin, Michael W. Wolff
Summary: Accurate and rapid quantification of virus titers is crucial in viral vectors and vaccines manufacturing. Current gold standard assays lack true process analytical monitoring. Flow cytometry and quantitative polymerase chain reaction offer advantages for rapid quantification, but require method optimization. Different approaches for assessing infectious viruses, including viral nucleic acid quantification and flow cytometric analysis, were compared using a model baculovirus. Staining viral surface proteins proved to be a fast and feasible approach for enveloped viruses, while labeling viral (m)RNA in infected cells showed potential but needs further research.
Article
Biotechnology & Applied Microbiology
Keven Lothert, Yasmina M. J. Harsy, Patrick Endres, Egbert Mueller, Michael W. Wolff
Summary: Recently, the use of restricted access media (RAM) in multimodal chromatography for nanoparticles purification has gained attention. This technique combines size exclusion and adsorptive interaction to selectively remove impurities while allowing the passage of the target virus. Various RAM resins were evaluated for the purification of Orf virus, and the results showed that different columns have different performance in DNA and protein removal, as well as regeneration potential. The choice of RAM resins should be based on the sample composition and the desired number of application cycles.
ENGINEERING IN LIFE SCIENCES
(2023)
Article
Biotechnology & Applied Microbiology
Carolin A. Lappoehn, Arne M. Oestreich, Robin Stei, Linus G. Weber, Lea Maerz, Michael W. Wolff
Summary: The article describes a method of increasing the production yield of the insect metalloproteinase inhibitor (IMPI) by adding a C-terminal C-tag. The C-tag not only enhances the yield but also simplifies the downstream processing without affecting the IMPI activity.
JOURNAL OF BIOSCIENCE AND BIOENGINEERING
(2023)
Article
Biochemical Research Methods
Carolin A. Lappohn, Lea Maerz, Robin Stei, Linus G. Weber, Michael W. Wolff
Summary: Antimicrobial peptides and proteins (AMPs) are potential substitutes for antibiotics in treating infections caused by multidrug-resistant bacteria. In this study, a high-throughput analytical immunoaffinity chromatography method was optimized to accurately quantify AMPs containing a C-tag, allowing reliable assessment of product quantity and quality.
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
(2023)
Article
Virology
Friederike Eilts, Yasmina M. J. Harsy, Keven Lothert, Felix Pagallies, Ralf Amann, Michael W. Wolff
Summary: The Orf virus (ORFV) has shown high stability during storage at various temperatures, and the addition of certain proteins, sugars, amino acids, detergents, and salts can further enhance its stability. This comprehensive data provides different options for a stable ORFV formulation, considering temperature, storage time, economic aspects, and downstream processing integrity.
Review
Biochemistry & Molecular Biology
Keven Lothert, Michael W. Wolff
Summary: This review summarizes the current evaluation of membrane-based affinity purifications for viruses and virus-like particles, including traditional resin and monolith approaches and the advantages of membrane applications. An overview of potential affinity ligands is given, as well as considerations of suitable affinity platform technologies, such as pseudo-affinity matrices like sulfated cellulose membrane adsorbers.
Article
Medicine, Research & Experimental
Frederik Meierrieks, Ahmad Kour, Marvin Paetz, Karl Pflanz, Michael W. Wolff, Andreas Pickl
Summary: This study compared commonly used analytical methods with advanced methods for determining AAV genome titer, capsid titer, and transducing titer. The use of advanced methods provided faster and more robust results, increased sample throughput, and reduced active bench work time.
MOLECULAR THERAPY-METHODS & CLINICAL DEVELOPMENT
(2023)
Article
Biotechnology & Applied Microbiology
Keven Lothert, Felix Pagallies, Thomas Feger, Ralf Amann, Michael W. Wolff
JOURNAL OF BIOTECHNOLOGY
(2020)
Article
Biotechnology & Applied Microbiology
Keven Lothert, Felix Pagallies, Friederike Eilts, Arabi Sivanesapillai, Martin Hardt, Anna Moebus, Thomas Feger, Ralf Amann, Michael W. Wolff
JOURNAL OF BIOTECHNOLOGY
(2020)