• Quality Control Testing, Characterization and Critical Quality Attributes of Adeno‐Associated Virus Vectors Used for Human Gene Therapy

    15 days ago - By Wiley

    This article describes quality control testing and characterization of adeno‐associated virus gene therapy vectors for clinical product development. It explores the relationship between AAV vector design and manufacturing process design with product critical quality attributes required for safety and durable efficacious expression, with emphasis on vector immunogenicity.
    Abstract
    For adeno‐associated virus ‐based human gene therapy, challenges for the translation of promising research results to successful clinical development include optimization of vector design and manufacturing...
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  • Evaluation of the Single‐Use Fixed‐Bed Bioreactors in Scalable Virus Production

    Evaluation of the Single‐Use Fixed‐Bed Bioreactors in Scalable Virus Production

    15 days ago - By Wiley

    Adherent cells can attach and grow in three‐dimensional fixed‐bed matrix. The single use disposable upstream technology has been implemented in many different viral vector and vaccine productions. Main process steps in viral production contain cell expansion phase, induction of the virus production and harvest.
    Abstract
    The accelerating development of gene therapy from research towards clinical trials and beyond has elevated the demand for practical viral vector‐manufacturing solutions. The use of disposable upstream technology is gaining traction in clinical manufacturing. Packed‐bed or...
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  • Outside Front Cover:

    Outside Front Cover:

    15 days ago - By Wiley

    Stable cell lines provide scalable and high yielding production systems enabling the development of efficient manufacturing bioprocesses, essential for the supply of viral vectors for gene and cell therapies. The establishment of lentiviral vector producer cell lines is however very challenging. In this review, the major bottlenecks and achievements in the development of lentiviral vector stable cell lines are discussed. This is reported by Mariana V. Ferreira, Elisa T. Cabral, Ana Sofia Coroadinha in the article 2000017 .
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  • Homologous Recombination Offers Advantages over Transposition‐Based Systems to Generate Recombinant Baculovirus for Adeno‐Associated Viral Vector Production

    Homologous Recombination Offers Advantages over Transposition‐Based Systems to Generate Recombinant Baculovirus for Adeno‐Associated Viral Vector Production

    15 days ago - By Wiley

    The baculovirus/insect cell is a standard platform for manufacturing of adeno‐associated viral vectors. This study compares homologous recombination and transposition to generate the baculovirus expressing vectors. Both methods allow generation of high titers of AAV vectors, but BEVs generated by HR are genetically more stable and devoid of any bacterial DNA sequences.
    Abstract
    Viral vectors have a great potential for gene delivery, but manufacturing is a big challenge for the industry. The baculovirus‐insect cell is one of the most scalable platforms to produce recombinant...
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  • Separating Empty and Full Recombinant Adeno‐Associated Virus Particles Using Isocratic Anion Exchange Chromatography

    Separating Empty and Full Recombinant Adeno‐Associated Virus Particles Using Isocratic Anion Exchange Chromatography

    15 days ago - By Wiley

    Robust and scalable separation of empty particles from recombinant adeno‐associated virus vectors is key in rAAV production. This separation is currently achieved via linear gradient elution chromatography which is challenging to implement at large scale. Improved separation resolution is demonstrated between the empty and full particles by combining NaCl and MgCl 2 as eluents, enabling an isocratic anion exchange chromatography separation.
    Abstract
    The development of recombinant adeno‐associated virus gene therapies is becoming an increasing priority in the biotherapeutic landscape. One...
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  • Production of Modified Vaccinia Ankara Virus by Intensified Cell Cultures: A Comparison of Platform Technologies for Viral Vector Production

    Production of Modified Vaccinia Ankara Virus by Intensified Cell Cultures: A Comparison of Platform Technologies for Viral Vector Production

    15 days ago - By Wiley

    Modified Vaccinia Ankara virus is a viral vector used for gene therapies. Here, MVA virus is produced with AGE1.CR.pIX suspension cells using different platform technologies. The authors then compared and discussed the pros and cons between the different platform technologies, based on the virus production yields and other criteria such as scalability and process robustness.
    Abstract
    Modified Vaccinia Ankara virus is a promising vector for vaccination against various challenging pathogens or the treatment of some types of cancers, requiring a high amount of virions per dose for vaccination...
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