~Introduction of quality requirements for stable PFS development for biopharmaceuticals, from material/product development to post-marketing response, and case studies on protein aggregation~
<<Key Points of This Book>> ■ The Status of Prefilled Syringes in the Medical Market Challenges of Self-Administration and GMP & QMS Management in Medical Product Manufacturing ■ Standard Testing of Prefilled Syringes in Japan, Europe, and the U.S. ~Current Situation and Differences in Pharmaceutical Regulatory Harmonization~ ■ Challenges to Consider and Required Quality Components for Prefilled Biopharmaceuticals ~Specific Development Examples from the Perspective of Syringe Manufacturing~ ■ Required Container Materials and Packaging Design Flow for Syringe Materials ~Basic Requirements and Adaptation to Drug Properties~ ■ Development Case of the Antibody Drug Actemra ~Post-Marketing - Appropriate Use and Actual Complaint Reporting~ ■ Points of Ease of Use and Areas for Improvement of Prefilled Kit Formulations from a Physician's Perspective ~How to Recognize Mistakes and Prevent Errors~ ■ Mechanisms of Aggregate Formation in Biopharmaceuticals and Key Points for Suppression ~Towards Stabilization of Formulations~ ■ Minimization of Aggregates in Biopharmaceuticals ~Introduction of Existing Technologies for Aggregate Removal and Suppression in Antibody Drugs, and Development Trends of New Aggregate Removal/Suppression Technologies~ ■ Understanding and Controlling Antibody Aggregation Mechanisms for the Purpose of Building Bioprocesses (Antibody Production CHO Cell Lines) ~Examples of Protein Aggregation~
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■Authors Formulation Development Advisor Eiji Watanabe Hiduki Nishi, Nishi Packaging Specialist Office Tsutomu Ueda, Terumo Corporation Others ■Table of Contents Chapter 1 Latest Information and Future Challenges of Prefilled Syringe/Kit Products Chapter 2 Regulatory Standards and Testing of Pharmacopeias in the Three Regions (Japan, Europe, and the U.S.) for Prefilled Syringes Chapter 3 Material Properties and Design of Prefilled Syringes - Considerations and Necessary Testing Items During Design Chapter 4 Design of Prefilled Syringes Section 1 Container and Packaging Design of Prefilled Syringes Section 2 Safety of Prefilled Syringe Devices from the Perspective of Pharmaceutical Companies - Actual Report Cases and Corporate Activities for Proper Use Section 3 Design of Prefilled Kit Formulations Considered Easy to Use and Required in the Field by Physicians Chapter 5 Enhancing Safety in Biopharmaceuticals and Effective Supply of Prefilled Syringe Formulations Section 1 Suppressing Protein Aggregation and Stabilizing Formulations - Mechanisms of Aggregate Formation and Suppression in Prefilled Syringes Section 2 Minimizing Aggregates in Biopharmaceuticals - Removal of Aggregates and Suppression of Aggregation in Antibody Drugs Section 3 Aggregate Formation and Control in Cultivation Processes - Focusing on Antibody-Producing CHO Cells
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