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Article
Biochemistry & Molecular Biology
Jennifer Julia Labisch et al.
Summary: Scaling up the purification of lentiviral vectors using membrane modules revealed that scaling of the flow rate is crucial and must be related to the membrane area of the first layer. By using this scaling approach, we were able to purify 980 mL of lentiviral vectors with a recovery rate of 68%.
Review
Chemistry, Analytical
Jennifer J. Labisch et al.
Summary: Steric exclusion chromatography (SXC) is a purification method based on the steric exclusion effects of polyethylene glycol (PEG) from the surface of the target. This gentle method has been widely used for sensitive targets and this review summarizes the findings and applications of SXC in the past 11 years. It also discusses critical process parameters for successful implementation of the method.
Article
Biochemistry & Molecular Biology
Friederike Eilts et al.
Summary: This study investigated the application of latex particles in steric exclusion chromatography and found that aggregation and pore blockage were limitations in the process. The kinetics of aggregation rather than the size of aggregates influenced the recovery. Additionally, it was found that functionalized polystyrene particles had limitations in representing biological nanoparticles.
Article
Biochemical Research Methods
Jennifer J. Labisch et al.
Summary: This study successfully identified optimal process parameters for steric exclusion chromatography to purify lentiviral vectors, achieving high recoveries of lentiviral vector particles and infectious particles. The method showed high potential for fragile enveloped viral vectors as it efficiently removed impurities.
JOURNAL OF CHROMATOGRAPHY A
(2022)
Article
Biochemistry & Molecular Biology
Friederike Eilts et al.
Summary: Steric exclusion chromatography (SXC) is a promising method for purifying biological macromolecules. Several purification tasks with SXC have shown high yields and impurity removal. However, the effect of different process parameters and the limitations of SXC are not well understood. This study investigated the precipitation behavior and SXC adaptation for a specific vector, and found that contact time, membrane pore size, and ion type and concentration significantly influenced the recovery rate. The findings of this study are important for clarifying the limitations of SXC and improving its successful adaptation.
Review
Biochemical Research Methods
Ana Sofia Moreira et al.
Summary: Lentiviral vectors (LVs) are increasingly used in gene and cell therapies due to their ability to integrate the genome in both dividing and nondividing cells. The production and purification processes have evolved significantly, but the demand for higher purity LVs is driving the development of new materials and strategies. Large-scale LV manufacturing still relies on adherent cell culture, with the industry moving towards suspension cultures, and purification strategies mainly involve batch chromatography and membrane technology. New solutions are being developed to enhance production schemes and expand clinical applications.
BIOTECHNOLOGY JOURNAL
(2021)
Article
Biotechnology & Applied Microbiology
Marc D. Hein et al.
Summary: A cell culture-based production process for OP7 was established, demonstrating its potential as an antiviral treatment. UV irradiation was used to inactivate harmful STV and preserve the efficacy of OP7. Purification and concentration of the produced OP7 material was achieved using steric exclusion chromatography, and its safety and therapeutic effect were confirmed in mouse experiments.
APPLIED MICROBIOLOGY AND BIOTECHNOLOGY
(2021)
Article
Biotechnology & Applied Microbiology
Pavel Marichal-Gallardo et al.
Summary: Membrane-based steric exclusion chromatography (SXC) is proposed as a universal capture step for purification of adeno-associated virus (AAV) gene transfer vectors, regardless of their serotype and surface characteristics. This inexpensive and single-use method allows for efficient concentration, purification, and re-buffering of AAV particles with high yields and impurity clearance. SXC could potentially be scaled up for industrial use on units of nearly 20 m(2).
HUMAN GENE THERAPY
(2021)
Review
Virology
Christopher Perry et al.
Summary: This comprehensive review discusses the importance of individual bioprocess operations in lentiviral vector (LV) production, emphasizing the role of envelope proteins and bioprocessing on LVs. It explores considerations for optimization and scalability during production, as well as key steps such as purification and quantification of LVs.
Article
Multidisciplinary Sciences
Jennifer J. Labisch et al.
Summary: The study developed a real-time imaging method for quantifying the infectious titer of lentiviral vectors, which showed lower standard deviation and a broader linear range compared to traditional methods, enabling real-time titer results.
Review
Virology
Roman P. Labbe et al.
Summary: Lentiviral vectors are crucial in the development of T cell therapies such as tisagenlecleucel, axicabtagene ciloleucel, and brexucabtagene autoleucel. However, obstacles remain in making these therapies widely available. The development of GMP-compliant technologies will play a key role in advancing lentiviral vector-engineered T cell therapies.
Review
Immunology
Aline Do Minh et al.
Summary: Viral vectors and viral vaccines play crucial roles in disease prevention and treatment, varying from infectious diseases control to genetic diseases and cancers treatment. It is noteworthy that extracellular vesicles (EVs) share similarities with enveloped viruses and may be present in the final formulation of viral products.
Review
Biochemistry & Molecular Biology
Jote T. Bulcha et al.
Summary: The field of gene therapy has made significant progress in combating human diseases and providing hope to patients and families with limited treatment options, but it has also faced setbacks. Viral-based vectors have played a crucial role in developing powerful drug platforms, but challenges still limit their full potential.
SIGNAL TRANSDUCTION AND TARGETED THERAPY
(2021)
Article
Biochemical Research Methods
Keven Lothert et al.
JOURNAL OF VIROLOGICAL METHODS
(2020)
Article
Multidisciplinary Sciences
Keven Lothert et al.
SCIENTIFIC REPORTS
(2020)
Article
Biotechnology & Applied Microbiology
Keven Lothert et al.
JOURNAL OF BIOTECHNOLOGY
(2020)
Review
Biotechnology & Applied Microbiology
Samantha L. Ginn et al.
JOURNAL OF GENE MEDICINE
(2018)
Article
Biochemical Research Methods
Alesia Levanova et al.
JOURNAL OF CHROMATOGRAPHY A
(2018)
Article
Biochemical Research Methods
Pavel Marichal-Gallardo et al.
JOURNAL OF CHROMATOGRAPHY A
(2017)
Article
Biochemical Research Methods
Pete Gagnon et al.
JOURNAL OF CHROMATOGRAPHY A
(2014)
Article
Biochemical Research Methods
Jeremy Lee et al.
JOURNAL OF CHROMATOGRAPHY A
(2012)
Article
Chemistry, Multidisciplinary
Yih Horng Tan et al.
