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Borries Demeler - One of the best experts on this subject based on the ideXlab platform.

  • moving analytical ultracentrifugation software to a Good Manufacturing Practices gmp environment
    PLOS Computational Biology, 2020
    Co-Authors: Alexey Savelyev, Borries Demeler, Gary E Gorbet, Amy Henrickson
    Abstract:

    Recent advances in instrumentation have moved analytical ultracentrifugation (AUC) closer to a possible validation in a Good Manufacturing Practices (GMP) environment. In order for AUC to be validated for a GMP environment, stringent requirements need to be satisfied; analysis procedures must be evaluated for consistency and reproducibility, and GMP capable data acquisition software needs to be developed and validated. These requirements extend to multiple regulatory aspects, covering documentation of instrument hardware functionality, data handling and software for data acquisition and data analysis, process control, audit trails and automation. Here we review the requirements for GMP validation of data acquisition software and illustrate software solutions based on UltraScan that address these requirements as far as they relate to the operation and data handling in conjunction with the latest analytical ultracentrifuge, the Optima AUC by Beckman Coulter. The software targets the needs of regulatory agencies, where AUC plays a critical role in the solution-based characterization of biopolymers and macromolecular assemblies. Biopharmaceutical and regulatory agencies rely heavily on this technique for characterizations of pharmaceutical formulations, biosimilars, injectables, nanoparticles, and other soluble therapeutics. Because of its resolving power, AUC is a favorite application, despite the current lack of GMP validation. We believe that recent advances in standards, hardware, and software presented in this work manage to bridge this gap and allow AUC to be routinely used in a GMP environment. AUC has great potential to provide more detailed information, at higher resolution, and with greater confidence than other analytical techniques, and our software satisfies an urgent need for AUC operation in the GMP environment. The software, including documentation, are publicly available for free download from Github. The multi-platform software is licensed by the LGPL v.3 open source license and supports Windows, Mac and Linux platforms. Installation instructions and a mailing list are available from ultrascan.aucsolutions.com.

Ivana Ferrero - One of the best experts on this subject based on the ideXlab platform.

  • cytokines induced killer cells produced in Good Manufacturing Practices conditions identification of the most advantageous and safest expansion method in terms of viability cellular growth and identity
    Journal of Translational Medicine, 2018
    Co-Authors: Sara Castiglia, Aloe Adamini, Deborah Rustichelli, Laura Castello, Katia Mareschi, Giuseppe Pinnetta, Marco Leone, Alessandra Mandese, Ivana Ferrero
    Abstract:

    Cytokine-induced killer (CIK) cells are a very promising cell population raising growing interest in the field of cellular antitumor therapy. The aim of our study was to validate the most advantageous expansion method for this advanced therapy medicinal product (ATMP) and to translate it from preclinical field to Good Manufacturing Practices (GMP). GMP ensures that ATMP are consistently produced and controlled to the quality standards required to their intended use. For this reason, the use of the xenogenic sera tended to be minimized by GMP for their high variability and the associated risk of transmitting infectious agents. We decided to replace Fetal Bovine Serum (FBS), largely used as medium supplement for CIKs expansion, with other culture media. Firstly, Human Serum (HS) and Human Pool Plasma (HPP) were tested as medium supplements giving not compliant results to acceptance criteria, established for CIKs, probably for the great batch to batch variability. Consequently, we decided to test three different serum free expansion media: X-VIVO 15, (largely used by other groups) and Tex Macs and Cell Genix GMP SCGM: two GMP manufactured media. We performed a validation consisting in three run-sand even if the small number of experiments didn’t permit us to obtained statistical results we demonstrated that both X-VIVO 15 and Tex Macs fulfilled the quality standards in terms of cellular growth, viability and identity while Cell Genix GMP SCGM resulted not compliant as it caused some technical problems such as high mortality. In conclusion, these preclinical validation data lay the bases for a GMP-compliant process to improve the CIKs expansion method.

  • Cytokines induced killer cells produced in Good Manufacturing Practices conditions: identification of the most advantageous and safest expansion method in terms of viability, cellular growth and identity
    'Springer Science and Business Media LLC', 2018
    Co-Authors: Sara Castiglia, Aloe Adamini, Deborah Rustichelli, Laura Castello, Katia Mareschi, Giuseppe Pinnetta, Marco Leone, Alessandra Mandese, Ivana Ferrero, Giulia Mesiano
    Abstract:

    Abstract Background Cytokine-induced killer (CIK) cells are a very promising cell population raising growing interest in the field of cellular antitumor therapy. The aim of our study was to validate the most advantageous expansion method for this advanced therapy medicinal product (ATMP) and to translate it from preclinical field to Good Manufacturing Practices (GMP). GMP ensures that ATMP are consistently produced and controlled to the quality standards required to their intended use. For this reason, the use of the xenogenic sera tended to be minimized by GMP for their high variability and the associated risk of transmitting infectious agents. Results We decided to replace Fetal Bovine Serum (FBS), largely used as medium supplement for CIKs expansion, with other culture media. Firstly, Human Serum (HS) and Human Pool Plasma (HPP) were tested as medium supplements giving not compliant results to acceptance criteria, established for CIKs, probably for the great batch to batch variability. Consequently, we decided to test three different serum free expansion media: X-VIVO 15, (largely used by other groups) and Tex Macs and Cell Genix GMP SCGM: two GMP manufactured media. We performed a validation consisting in three run-sand even if the small number of experiments didn’t permit us to obtained statistical results we demonstrated that both X-VIVO 15 and Tex Macs fulfilled the quality standards in terms of cellular growth, viability and identity while Cell Genix GMP SCGM resulted not compliant as it caused some technical problems such as high mortality. Conclusion In conclusion, these preclinical validation data lay the bases for a GMP-compliant process to improve the CIKs expansion method

Katia Mareschi - One of the best experts on this subject based on the ideXlab platform.

  • cytokines induced killer cells produced in Good Manufacturing Practices conditions identification of the most advantageous and safest expansion method in terms of viability cellular growth and identity
    Journal of Translational Medicine, 2018
    Co-Authors: Sara Castiglia, Aloe Adamini, Deborah Rustichelli, Laura Castello, Katia Mareschi, Giuseppe Pinnetta, Marco Leone, Alessandra Mandese, Ivana Ferrero
    Abstract:

    Cytokine-induced killer (CIK) cells are a very promising cell population raising growing interest in the field of cellular antitumor therapy. The aim of our study was to validate the most advantageous expansion method for this advanced therapy medicinal product (ATMP) and to translate it from preclinical field to Good Manufacturing Practices (GMP). GMP ensures that ATMP are consistently produced and controlled to the quality standards required to their intended use. For this reason, the use of the xenogenic sera tended to be minimized by GMP for their high variability and the associated risk of transmitting infectious agents. We decided to replace Fetal Bovine Serum (FBS), largely used as medium supplement for CIKs expansion, with other culture media. Firstly, Human Serum (HS) and Human Pool Plasma (HPP) were tested as medium supplements giving not compliant results to acceptance criteria, established for CIKs, probably for the great batch to batch variability. Consequently, we decided to test three different serum free expansion media: X-VIVO 15, (largely used by other groups) and Tex Macs and Cell Genix GMP SCGM: two GMP manufactured media. We performed a validation consisting in three run-sand even if the small number of experiments didn’t permit us to obtained statistical results we demonstrated that both X-VIVO 15 and Tex Macs fulfilled the quality standards in terms of cellular growth, viability and identity while Cell Genix GMP SCGM resulted not compliant as it caused some technical problems such as high mortality. In conclusion, these preclinical validation data lay the bases for a GMP-compliant process to improve the CIKs expansion method.

  • Cytokines induced killer cells produced in Good Manufacturing Practices conditions: identification of the most advantageous and safest expansion method in terms of viability, cellular growth and identity
    'Springer Science and Business Media LLC', 2018
    Co-Authors: Sara Castiglia, Aloe Adamini, Deborah Rustichelli, Laura Castello, Katia Mareschi, Giuseppe Pinnetta, Marco Leone, Alessandra Mandese, Ivana Ferrero, Giulia Mesiano
    Abstract:

    Abstract Background Cytokine-induced killer (CIK) cells are a very promising cell population raising growing interest in the field of cellular antitumor therapy. The aim of our study was to validate the most advantageous expansion method for this advanced therapy medicinal product (ATMP) and to translate it from preclinical field to Good Manufacturing Practices (GMP). GMP ensures that ATMP are consistently produced and controlled to the quality standards required to their intended use. For this reason, the use of the xenogenic sera tended to be minimized by GMP for their high variability and the associated risk of transmitting infectious agents. Results We decided to replace Fetal Bovine Serum (FBS), largely used as medium supplement for CIKs expansion, with other culture media. Firstly, Human Serum (HS) and Human Pool Plasma (HPP) were tested as medium supplements giving not compliant results to acceptance criteria, established for CIKs, probably for the great batch to batch variability. Consequently, we decided to test three different serum free expansion media: X-VIVO 15, (largely used by other groups) and Tex Macs and Cell Genix GMP SCGM: two GMP manufactured media. We performed a validation consisting in three run-sand even if the small number of experiments didn’t permit us to obtained statistical results we demonstrated that both X-VIVO 15 and Tex Macs fulfilled the quality standards in terms of cellular growth, viability and identity while Cell Genix GMP SCGM resulted not compliant as it caused some technical problems such as high mortality. Conclusion In conclusion, these preclinical validation data lay the bases for a GMP-compliant process to improve the CIKs expansion method

Sara Castiglia - One of the best experts on this subject based on the ideXlab platform.

  • cytokines induced killer cells produced in Good Manufacturing Practices conditions identification of the most advantageous and safest expansion method in terms of viability cellular growth and identity
    Journal of Translational Medicine, 2018
    Co-Authors: Sara Castiglia, Aloe Adamini, Deborah Rustichelli, Laura Castello, Katia Mareschi, Giuseppe Pinnetta, Marco Leone, Alessandra Mandese, Ivana Ferrero
    Abstract:

    Cytokine-induced killer (CIK) cells are a very promising cell population raising growing interest in the field of cellular antitumor therapy. The aim of our study was to validate the most advantageous expansion method for this advanced therapy medicinal product (ATMP) and to translate it from preclinical field to Good Manufacturing Practices (GMP). GMP ensures that ATMP are consistently produced and controlled to the quality standards required to their intended use. For this reason, the use of the xenogenic sera tended to be minimized by GMP for their high variability and the associated risk of transmitting infectious agents. We decided to replace Fetal Bovine Serum (FBS), largely used as medium supplement for CIKs expansion, with other culture media. Firstly, Human Serum (HS) and Human Pool Plasma (HPP) were tested as medium supplements giving not compliant results to acceptance criteria, established for CIKs, probably for the great batch to batch variability. Consequently, we decided to test three different serum free expansion media: X-VIVO 15, (largely used by other groups) and Tex Macs and Cell Genix GMP SCGM: two GMP manufactured media. We performed a validation consisting in three run-sand even if the small number of experiments didn’t permit us to obtained statistical results we demonstrated that both X-VIVO 15 and Tex Macs fulfilled the quality standards in terms of cellular growth, viability and identity while Cell Genix GMP SCGM resulted not compliant as it caused some technical problems such as high mortality. In conclusion, these preclinical validation data lay the bases for a GMP-compliant process to improve the CIKs expansion method.

  • Cytokines induced killer cells produced in Good Manufacturing Practices conditions: identification of the most advantageous and safest expansion method in terms of viability, cellular growth and identity
    'Springer Science and Business Media LLC', 2018
    Co-Authors: Sara Castiglia, Aloe Adamini, Deborah Rustichelli, Laura Castello, Katia Mareschi, Giuseppe Pinnetta, Marco Leone, Alessandra Mandese, Ivana Ferrero, Giulia Mesiano
    Abstract:

    Abstract Background Cytokine-induced killer (CIK) cells are a very promising cell population raising growing interest in the field of cellular antitumor therapy. The aim of our study was to validate the most advantageous expansion method for this advanced therapy medicinal product (ATMP) and to translate it from preclinical field to Good Manufacturing Practices (GMP). GMP ensures that ATMP are consistently produced and controlled to the quality standards required to their intended use. For this reason, the use of the xenogenic sera tended to be minimized by GMP for their high variability and the associated risk of transmitting infectious agents. Results We decided to replace Fetal Bovine Serum (FBS), largely used as medium supplement for CIKs expansion, with other culture media. Firstly, Human Serum (HS) and Human Pool Plasma (HPP) were tested as medium supplements giving not compliant results to acceptance criteria, established for CIKs, probably for the great batch to batch variability. Consequently, we decided to test three different serum free expansion media: X-VIVO 15, (largely used by other groups) and Tex Macs and Cell Genix GMP SCGM: two GMP manufactured media. We performed a validation consisting in three run-sand even if the small number of experiments didn’t permit us to obtained statistical results we demonstrated that both X-VIVO 15 and Tex Macs fulfilled the quality standards in terms of cellular growth, viability and identity while Cell Genix GMP SCGM resulted not compliant as it caused some technical problems such as high mortality. Conclusion In conclusion, these preclinical validation data lay the bases for a GMP-compliant process to improve the CIKs expansion method

Scott R. Burger - One of the best experts on this subject based on the ideXlab platform.

  • Design and operation of a current Good Manufacturing Practices cell-engineering laboratory.
    Cytotherapy, 2000
    Co-Authors: Scott R. Burger
    Abstract:

    Summary Medical centers and biotechnology companies active in cellular and gene therapy increasingly are working to design and build clinical laboratories capable of performing cellular engineering and vector production using current Good Manufacturing Practices (cGMPs). Because cell engineering is a rapidly changing field, and definitions for cell engineering cGMPs are still being established, a cGMP cell-engineering laboratory most often should be designed with a broad range of potential applications in mind. While the laboratory facility is the most tangible aspect of cGMP, it represents only part of a larger process, which it must be designed and built to support.