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Image of - Therapeutic Protein Drug Products Practical Approaches To Formulation In The Laboratory | Manufacturing and The Clinical | Hardcover
Therapeutic Protein Drug Products Practical Approaches To Formulation In The Laboratory | Manufacturing and The Clinical | Hardcover

Therapeutic Protein Drug Products Practical Approaches To Formulation In The Laboratory | Manufacturing and The Clinical | Hardcover

by Meyer

Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed.

Highlights

  • binding-icon

    9781907568183

    ISBN:

  • binding-icon

    Meyer

    Author:

  • binding-icon

    200

    Pages:

  • binding-icon

    215 gm

    Weight:

  • langauage-icon

    English

    Language:

  • date-icon

    2012

    Year:

  • edition-icon

    1st Edition

    Edition:

  • binding-icon

    Hardcover

    Binding:

13354

16692

Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed.

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