Book: Development of Prefilled Syringes Suitable for Biopharmaceuticals

~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~

Technical and Reference Books