Titlebook: Challenges in Protein Product Development; Nicholas W. Warne,Hanns-Christian Mahler Book 2018 American Association of Pharmaceutical Scien

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Analytical Characterization and Predictive Tools for Highly Concentrated Protein Formulationsion of predictive tools used during early development, specific challenges for analytical methods, and extended characterization of rheological and structural properties. The application of predictive tools during clinical lead selection and early-stage development helps to assess whether a selected

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Practical Considerations for High Concentration Protein Formulationsgh concentration protein formulations have an increased tendency for high solution viscosity, physical stability sensitivities (aggregation/particulation), and non-Newtonian solution behavior (shear thinning) due to high shear rates. Process unit operations can be negatively impacted by these factor

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Development of Prefilled Syringe Combination Products for Biologicsther combination products offer patients the convenience of at-home self-administration. This can result in considerable cost savings compared to dosing in a clinical setting. PFS systems improve patient compliance and dosing accuracy, reduce overfill cost and waste, and can reduce sharps injuries (

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C Mini-pumpseutics in combination with particular usability needs. Introductory Sect. . reflects on the growing requirements on drug delivery devices for biologics in connection with new indications and user groups. Section . discusses the boundary conditions, physical basics and technical requirements. Section

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Container Closure Integrity Testing of Primary Containers for Parenteral Productsntent inside. Ensuring the CCI of a parenteral product package is essential during the entire lifecycle of a product. The chapter first reviews the U.S. FDA regulatory requirements on CCI. Regulations for several regulatory authorities outside the USA are also presented for comparison. From these re

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Foggingestricted to ion leaching or corrosion effects but also impacting adsorption phenomena. The formulation can creep up the walls forming a thin liquid layer on the inside of the containers. This layer is getting visible as product residues on the vial walls after a lyophilization process. This mechani

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