The Experts below are selected from a list of 15492 Experts worldwide ranked by ideXlab platform

Catherine Lacaze - One of the best experts on this subject based on the ideXlab platform.

  • the initial pharmaceutical development of an artesunate amodiaquine oral formulation for the treatment of malaria a public private partnership
    Malaria Journal, 2011
    Co-Authors: Catherine Lacaze, Tina Kauss, Jeanrene Kiechel, Antonella Caminiti, Fawaz Fawaz, Laure Terrassi, Sylvie Cua, Luc Grislai, V Navaratnam, Ellabes Ghezzoul
    Abstract:

    Background: Artemisinin-based combination therapy is currently recommended worldwide for the treatment of uncomplicated malaria. Fixed-dose combinations are preferred as they favour compliance. This paper reports on the initial phases of the pharmaceutical development of an artesunate-amodiaquine (ASAQ) bilayer co-formulation tablet, undertaken following pre-formulation studies by a network of scientists and industrials from institutions of both industrialized and low income countries. Methods: Pharmaceutical development was performed by a research laboratory at the University Bordeaux Segalen, School of Pharmacy, for feasibility and early stability studies of various drug formulations, further transferred to a company specialized in pharmaceutical development, and then provided to another company for clinical Batch Manufacturing. The work was conducted by a regional public-private not-for-profit network (TropiVal) within a larger Public Private partnership (the FACT project), set up by WHO/TDR, Medecins Sans Frontieres and the Drugs for Neglected Disease initiative (DNDi). Results: The main pharmaceutical goal was to combine in a solid oral form two incompatible active principles while preventing artesunate degradation under tropical conditions. Several options were attempted and failed to provide satisfactory stability results: incorporating artesunate in the external phase of the tablets, adding a pH regulator, alcoholic wet granulation, dry granulation, addition of an hydrophobic agent, tablet Manufacturing in controlled conditions. However, long-term stability could be achieved, in experimental Batches under GMP conditions, by physical separation of artesunate and amodiaquine in a bilayer co-formulation tablet in alu-alu blisters. Conduction of the workplan was monitored by DNDi. Conclusions: Collaborations between research and industrial groups greatly accelerated the process of development of the bi-layered ASAQ tablet. Lack of public funding was the main obstacle hampering the development process, and no intellectual property right was claimed. This approach resulted in a rapid technology transfer to the drug company Sanofi-Aventis, finalizing the process of development, registration and WHO prequalification of the fixed-dose co-formulation together with DNDi. The bi-layered tablet is made available under the names of Coarsucam ® and Artesunate amodiaquine Winthrop ® , Sanofi-Aventis. The issue related to the difficulty of public institutions to valorise their participation in such initiative by lack of priority and funding of applied research is discussed.

  • the initial pharmaceutical development of an artesunate amodiaquine oral formulation for the treatment of malaria a public private partnership
    Malaria Journal, 2011
    Co-Authors: Catherine Lacaze, Tina Kauss, Jeanrene Kiechel, Antonella Caminiti, Fawaz Fawaz, V Navaratnam, Laurent Terrassin, Sylvie Cuart, Luc Grislain, Bellabes Ghezzoul
    Abstract:

    Artemisinin-based combination therapy is currently recommended worldwide for the treatment of uncomplicated malaria. Fixed-dose combinations are preferred as they favour compliance. This paper reports on the initial phases of the pharmaceutical development of an artesunate-amodiaquine (ASAQ) bilayer co-formulation tablet, undertaken following pre-formulation studies by a network of scientists and industrials from institutions of both industrialized and low income countries. Pharmaceutical development was performed by a research laboratory at the University Bordeaux Segalen, School of Pharmacy, for feasibility and early stability studies of various drug formulations, further transferred to a company specialized in pharmaceutical development, and then provided to another company for clinical Batch Manufacturing. The work was conducted by a regional public-private not-for-profit network (TropiVal) within a larger Public Private partnership (the FACT project), set up by WHO/TDR, Medecins Sans Frontieres and the Drugs for Neglected Disease initiative (DNDi). The main pharmaceutical goal was to combine in a solid oral form two incompatible active principles while preventing artesunate degradation under tropical conditions. Several options were attempted and failed to provide satisfactory stability results: incorporating artesunate in the external phase of the tablets, adding a pH regulator, alcoholic wet granulation, dry granulation, addition of an hydrophobic agent, tablet Manufacturing in controlled conditions. However, long-term stability could be achieved, in experimental Batches under GMP conditions, by physical separation of artesunate and amodiaquine in a bilayer co-formulation tablet in alu-alu blisters. Conduction of the workplan was monitored by DNDi. Collaborations between research and industrial groups greatly accelerated the process of development of the bi-layered ASAQ tablet. Lack of public funding was the main obstacle hampering the development process, and no intellectual property right was claimed. This approach resulted in a rapid technology transfer to the drug company Sanofi-Aventis, finalizing the process of development, registration and WHO pre-qualification of the fixed-dose co-formulation together with DNDi. The bi-layered tablet is made available under the names of Coarsucam® and Artesunate amodiaquine Winthrop®, Sanofi-Aventis. The issue related to the difficulty of public institutions to valorise their participation in such initiative by lack of priority and funding of applied research is discussed.

Valentina D’atri - One of the best experts on this subject based on the ideXlab platform.

  • Determination of size variants by CE-SDS for approved therapeutic antibodies: Key implications of subclasses and light chain specificities
    Journal of Pharmaceutical and Biomedical Analysis, 2020
    Co-Authors: Elsa Wagner, Olivier Colas, Stephane Chenu, Alexandre Goyon, Amarande Murisier, Sarah Cianférani, Yannis Francois, Szabolcs Fekete, Davy Guillarme, Valentina D’atri
    Abstract:

    In the present work, a generic non-reducing capillary electrophoresis sodium dodecyl sulphate (nrCE-SDS) method was tested for a wide range of 26 FDA and EMA approved monoclonal antibodies (mAbs) and 2 antibody drug conjugates (ADCs) as well as for the NISTmab, in a QC environment (e.g. testing quality requirements for Batch Manufacturing or Batch release). This method allows obtaining rapidly and accurately the amount of size variants in drug products within about 40 min and may be used for Batch release and consistency as well as for stability and shelf-life. First, the method repeatability was found to be excellent in terms of relative migration times and relative proportions of fragments (average RSD values of 0.3 and 0.2 %, on relative migration times and relative percentages of fragments, respectively), thanks to the addition of an internal standard. A panel of chimeric, humanized and human mAbs were tested, belonging to different subclasses (heavy chain gamma 1, 2, 2/4 and 4) and light chain types (κ or λ) and produced in different cell lines (CHO, NS0 and SP2/0). For all these biopharmaceutical products, the amount of H2L2 species was comprised between 90.9 % and 97.7 %, except for the two mAbs belonging to the IgG1λ subclass, namely avelumab and belimumab, which were prone to partial reduction during the sample preparation at 70 °C. Based on the CE-SDS results obtained for a diverse panel of therapeutic antibodies investigated in this study, and covering a wide range of structural and physico-chemical properties, a specification on the intact antibody content (H2L2) greater than 90 % can be achieved.

Ellabes Ghezzoul - One of the best experts on this subject based on the ideXlab platform.

  • the initial pharmaceutical development of an artesunate amodiaquine oral formulation for the treatment of malaria a public private partnership
    Malaria Journal, 2011
    Co-Authors: Catherine Lacaze, Tina Kauss, Jeanrene Kiechel, Antonella Caminiti, Fawaz Fawaz, Laure Terrassi, Sylvie Cua, Luc Grislai, V Navaratnam, Ellabes Ghezzoul
    Abstract:

    Background: Artemisinin-based combination therapy is currently recommended worldwide for the treatment of uncomplicated malaria. Fixed-dose combinations are preferred as they favour compliance. This paper reports on the initial phases of the pharmaceutical development of an artesunate-amodiaquine (ASAQ) bilayer co-formulation tablet, undertaken following pre-formulation studies by a network of scientists and industrials from institutions of both industrialized and low income countries. Methods: Pharmaceutical development was performed by a research laboratory at the University Bordeaux Segalen, School of Pharmacy, for feasibility and early stability studies of various drug formulations, further transferred to a company specialized in pharmaceutical development, and then provided to another company for clinical Batch Manufacturing. The work was conducted by a regional public-private not-for-profit network (TropiVal) within a larger Public Private partnership (the FACT project), set up by WHO/TDR, Medecins Sans Frontieres and the Drugs for Neglected Disease initiative (DNDi). Results: The main pharmaceutical goal was to combine in a solid oral form two incompatible active principles while preventing artesunate degradation under tropical conditions. Several options were attempted and failed to provide satisfactory stability results: incorporating artesunate in the external phase of the tablets, adding a pH regulator, alcoholic wet granulation, dry granulation, addition of an hydrophobic agent, tablet Manufacturing in controlled conditions. However, long-term stability could be achieved, in experimental Batches under GMP conditions, by physical separation of artesunate and amodiaquine in a bilayer co-formulation tablet in alu-alu blisters. Conduction of the workplan was monitored by DNDi. Conclusions: Collaborations between research and industrial groups greatly accelerated the process of development of the bi-layered ASAQ tablet. Lack of public funding was the main obstacle hampering the development process, and no intellectual property right was claimed. This approach resulted in a rapid technology transfer to the drug company Sanofi-Aventis, finalizing the process of development, registration and WHO prequalification of the fixed-dose co-formulation together with DNDi. The bi-layered tablet is made available under the names of Coarsucam ® and Artesunate amodiaquine Winthrop ® , Sanofi-Aventis. The issue related to the difficulty of public institutions to valorise their participation in such initiative by lack of priority and funding of applied research is discussed.

Bellabes Ghezzoul - One of the best experts on this subject based on the ideXlab platform.

  • the initial pharmaceutical development of an artesunate amodiaquine oral formulation for the treatment of malaria a public private partnership
    Malaria Journal, 2011
    Co-Authors: Catherine Lacaze, Tina Kauss, Jeanrene Kiechel, Antonella Caminiti, Fawaz Fawaz, V Navaratnam, Laurent Terrassin, Sylvie Cuart, Luc Grislain, Bellabes Ghezzoul
    Abstract:

    Artemisinin-based combination therapy is currently recommended worldwide for the treatment of uncomplicated malaria. Fixed-dose combinations are preferred as they favour compliance. This paper reports on the initial phases of the pharmaceutical development of an artesunate-amodiaquine (ASAQ) bilayer co-formulation tablet, undertaken following pre-formulation studies by a network of scientists and industrials from institutions of both industrialized and low income countries. Pharmaceutical development was performed by a research laboratory at the University Bordeaux Segalen, School of Pharmacy, for feasibility and early stability studies of various drug formulations, further transferred to a company specialized in pharmaceutical development, and then provided to another company for clinical Batch Manufacturing. The work was conducted by a regional public-private not-for-profit network (TropiVal) within a larger Public Private partnership (the FACT project), set up by WHO/TDR, Medecins Sans Frontieres and the Drugs for Neglected Disease initiative (DNDi). The main pharmaceutical goal was to combine in a solid oral form two incompatible active principles while preventing artesunate degradation under tropical conditions. Several options were attempted and failed to provide satisfactory stability results: incorporating artesunate in the external phase of the tablets, adding a pH regulator, alcoholic wet granulation, dry granulation, addition of an hydrophobic agent, tablet Manufacturing in controlled conditions. However, long-term stability could be achieved, in experimental Batches under GMP conditions, by physical separation of artesunate and amodiaquine in a bilayer co-formulation tablet in alu-alu blisters. Conduction of the workplan was monitored by DNDi. Collaborations between research and industrial groups greatly accelerated the process of development of the bi-layered ASAQ tablet. Lack of public funding was the main obstacle hampering the development process, and no intellectual property right was claimed. This approach resulted in a rapid technology transfer to the drug company Sanofi-Aventis, finalizing the process of development, registration and WHO pre-qualification of the fixed-dose co-formulation together with DNDi. The bi-layered tablet is made available under the names of Coarsucam® and Artesunate amodiaquine Winthrop®, Sanofi-Aventis. The issue related to the difficulty of public institutions to valorise their participation in such initiative by lack of priority and funding of applied research is discussed.

V Navaratnam - One of the best experts on this subject based on the ideXlab platform.

  • the initial pharmaceutical development of an artesunate amodiaquine oral formulation for the treatment of malaria a public private partnership
    Malaria Journal, 2011
    Co-Authors: Catherine Lacaze, Tina Kauss, Jeanrene Kiechel, Antonella Caminiti, Fawaz Fawaz, Laure Terrassi, Sylvie Cua, Luc Grislai, V Navaratnam, Ellabes Ghezzoul
    Abstract:

    Background: Artemisinin-based combination therapy is currently recommended worldwide for the treatment of uncomplicated malaria. Fixed-dose combinations are preferred as they favour compliance. This paper reports on the initial phases of the pharmaceutical development of an artesunate-amodiaquine (ASAQ) bilayer co-formulation tablet, undertaken following pre-formulation studies by a network of scientists and industrials from institutions of both industrialized and low income countries. Methods: Pharmaceutical development was performed by a research laboratory at the University Bordeaux Segalen, School of Pharmacy, for feasibility and early stability studies of various drug formulations, further transferred to a company specialized in pharmaceutical development, and then provided to another company for clinical Batch Manufacturing. The work was conducted by a regional public-private not-for-profit network (TropiVal) within a larger Public Private partnership (the FACT project), set up by WHO/TDR, Medecins Sans Frontieres and the Drugs for Neglected Disease initiative (DNDi). Results: The main pharmaceutical goal was to combine in a solid oral form two incompatible active principles while preventing artesunate degradation under tropical conditions. Several options were attempted and failed to provide satisfactory stability results: incorporating artesunate in the external phase of the tablets, adding a pH regulator, alcoholic wet granulation, dry granulation, addition of an hydrophobic agent, tablet Manufacturing in controlled conditions. However, long-term stability could be achieved, in experimental Batches under GMP conditions, by physical separation of artesunate and amodiaquine in a bilayer co-formulation tablet in alu-alu blisters. Conduction of the workplan was monitored by DNDi. Conclusions: Collaborations between research and industrial groups greatly accelerated the process of development of the bi-layered ASAQ tablet. Lack of public funding was the main obstacle hampering the development process, and no intellectual property right was claimed. This approach resulted in a rapid technology transfer to the drug company Sanofi-Aventis, finalizing the process of development, registration and WHO prequalification of the fixed-dose co-formulation together with DNDi. The bi-layered tablet is made available under the names of Coarsucam ® and Artesunate amodiaquine Winthrop ® , Sanofi-Aventis. The issue related to the difficulty of public institutions to valorise their participation in such initiative by lack of priority and funding of applied research is discussed.

  • the initial pharmaceutical development of an artesunate amodiaquine oral formulation for the treatment of malaria a public private partnership
    Malaria Journal, 2011
    Co-Authors: Catherine Lacaze, Tina Kauss, Jeanrene Kiechel, Antonella Caminiti, Fawaz Fawaz, V Navaratnam, Laurent Terrassin, Sylvie Cuart, Luc Grislain, Bellabes Ghezzoul
    Abstract:

    Artemisinin-based combination therapy is currently recommended worldwide for the treatment of uncomplicated malaria. Fixed-dose combinations are preferred as they favour compliance. This paper reports on the initial phases of the pharmaceutical development of an artesunate-amodiaquine (ASAQ) bilayer co-formulation tablet, undertaken following pre-formulation studies by a network of scientists and industrials from institutions of both industrialized and low income countries. Pharmaceutical development was performed by a research laboratory at the University Bordeaux Segalen, School of Pharmacy, for feasibility and early stability studies of various drug formulations, further transferred to a company specialized in pharmaceutical development, and then provided to another company for clinical Batch Manufacturing. The work was conducted by a regional public-private not-for-profit network (TropiVal) within a larger Public Private partnership (the FACT project), set up by WHO/TDR, Medecins Sans Frontieres and the Drugs for Neglected Disease initiative (DNDi). The main pharmaceutical goal was to combine in a solid oral form two incompatible active principles while preventing artesunate degradation under tropical conditions. Several options were attempted and failed to provide satisfactory stability results: incorporating artesunate in the external phase of the tablets, adding a pH regulator, alcoholic wet granulation, dry granulation, addition of an hydrophobic agent, tablet Manufacturing in controlled conditions. However, long-term stability could be achieved, in experimental Batches under GMP conditions, by physical separation of artesunate and amodiaquine in a bilayer co-formulation tablet in alu-alu blisters. Conduction of the workplan was monitored by DNDi. Collaborations between research and industrial groups greatly accelerated the process of development of the bi-layered ASAQ tablet. Lack of public funding was the main obstacle hampering the development process, and no intellectual property right was claimed. This approach resulted in a rapid technology transfer to the drug company Sanofi-Aventis, finalizing the process of development, registration and WHO pre-qualification of the fixed-dose co-formulation together with DNDi. The bi-layered tablet is made available under the names of Coarsucam® and Artesunate amodiaquine Winthrop®, Sanofi-Aventis. The issue related to the difficulty of public institutions to valorise their participation in such initiative by lack of priority and funding of applied research is discussed.