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  • Book
    Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe, editors.
    Contents:
    1 Challenges and Opportunities for Biotech Quality by Design
    2 Lessons Learned From Monoclonal Antibody Applications to the Office of Biotechnology Products Quality by Design Pilot Program
    3 Definitions and Scope of Key Elements of QbD
    4 An Overview of Quality by Design for Drug Product
    5 Development of Drug Product Formulations: Molecular Design and Early Candidates Screening
    6 Approaches for Early Developability Assessment of Proteins to Guide Quality by Design of Liquid Formulations
    7 Application of QbD Principles to Late-stage Formulation Development for Biological Liquid Products
    8 Application of QbD Principles for Lyophilized Formulation Development
    9 Drug Substance Frozen Storage and Thawing
    10 Quality by Design as Applied to Drug Substance Formulation using Ultrafiltration and Diafiltration
    11 A QbD Approach in the Development and Scale-up of Mixing Processes
    12 Application of QbD Elements in the Development and Scale-up of a Commercial Filtration Process
    13 Application of QbD Elements in the Development and Scale-up of Commercial Filling Process
    14 Lyophilization Process Design and Development Using QbD Principles
    15 Visible and Subvisible Protein Particle Inspection Within a QbD-based Strategy
    16 Quality by Design for Distribution of Environmentally Sensitive Pharmaceutical Products
    17 Quality by Design for Primary Container Components
    18 Devices and Combination Products for Biopharmaceuticals
    19 Applicability of QbD for Vaccine Drug Product Development
    20 Automation and High Throughput Technologies in Biopharmaceutical Drug Product Development with QbD Approaches
    21 Critical Quality Attributes, Specifications, and Control Strategy
    22 Multivariate Analysis for Process Understanding, Monitoring, Control and Optimization in Lyophilization Processes
    23 Using Mathematical Modeling and Prior Knowledge for QbD in Freeze-drying Processes
    24 Application of Multivariate Statistical Process Monitoring to Lyophilization Process
    25 Application of PAT in Real-time Monitoring and Controlling of Lyophilization Process
    26 Product Homogeneity Assessment during Validation of Biopharmaceutical Drug Product Manufacturing Processes
    27 Application of Quality by Design Principles to the Drug Product Technology Transfer Process
    28 Regulatory Considerations For Implementation of the QbD Paradigm for Biologics: Laying the Foundation for Product and Process Lifecycle Management.
    Digital Access Springer 2015