Sách giáo khoa Y Dược học: Analytical Techniques for Biopharmaceutical Development (Kỹ thuật phân tích nhằm phát triển Dược phẩm sinh học)

ROBERTO RODRIGUEZ-DIAZ - TIM WEHR - STEPHEN TUCK

ANALYTICAL TECHNIQUES FOR BIOPHARMACEUTICAL DEVELOPMENT

(KỸ THUẬT PHÂN TÍCH NHẰM PHÁT TRIỂN DƯỢC PHẨM SINH HỌC)

PUBLISHER: MARCEL DEKKER (2005)

THÔNG TIN CHUNG:

Tên sách: Analytical Techniques for Biopharmaceutical Development (tạm dịch: Kỹ thuật phân tích nhằm phát triển Dược phẩm sinh học).

Tác giả: Roberto Rodriguez-Diaz - Tim Wehr - Stephen Tuck.

NXB: Marcel Dekker (2005).

Thông số: 401 trang, 14 chương chính.

Dược phẩm có nguồn gốc sinh học hiện nay đang là hướng phát triển mới trong ngành công nghiệp dược phẩm, với tiềm năng lớn trong việc điều trị, an toàn, thân thiện, ít gây tác dụng phụ hơn so với dược phẩm tổng hợp. Cuốn sách dài hơn 400 trang này sẽ cung cấp cho độc giả, đặc biệt là các nhà nghiên cứu trong lĩnh vực công nghệ sinh học những kiến thức, kinh nghiệm trong việc phân tích nhằm phát triển các loại dược phẩm sinh học trong tương lai...

INTRODUCTION (GIỚI THIỆU):

Before the days of mass literacy, medicine was more art than science, and people recognized a pharmacy by the four traditional colored bottles that represent earth,fire, air, and water. Medicine has come a long way since the days of the apothecary with its impressive collection of powders and bottles; drugs today are highly regulated and must comply with standards set by the U.S., Europe, Japan, and other countries. A drug must be shown to be efficacious and meet rigorous standards of purity, composition, and potency before being approved for use in the patient population. These regulations provide confidence to the patient that a prescribed medicine will achieve its therapeutic goal. Whether in the form of a pill, a capsule, an injection, a tablespoon of syrup, or an inhaler, analytical methods ensure the identity, purity, potency, and ultimately the performance of these drugs.

Analytical methods are important not only in the development and manufacture of commercial biopharmaceutical drugs, they also play a vital role in the whole drug development life cycle. Drug discovery and preclinical research require development and application of analytical methodologies to support identification, quantitation, and characterization of lead molecules. It is difficult to perform a comparative potency assay on lead molecules if one does not know how much of each is going into the assay or how pure the molecule is. Analytical methods are typically developed, qualified, and validated in step with the clinical phase of the molecule. Techniques used during discovery and preclinical development will be qualified for basic performance. When the drug is approaching early human clinical trials, and compliance to regulations becomes the order of the day, the analytical scientist begins developing assays that International Conference on Harmonization (ICH) guidelines define as “appropriate for their intended applications.” Analytical methods will be required for characterizing the protein’s physical-chemical and biological properties, developing stable formulations, evaluating real-time and accelerated stability, process development, process validation, manufacturing, and quality control.

The objective of this book is to provide both an overview and practical uses of the techniques available to analytical scientists involved in the development and application of methods for protein-based biopharmaceutical drugs. The emphasis is on considering the analytical method in terms of the stage of the development process and its appropriateness for the intended application. The availability of techniques will reveal whether or not the analytical problem has a potential solution. Then will come the question of whether or not the technique is a truly appropriate solution. The theoretical considerations behind choosing the technique may be solid. However, the practicality of the method may not hold up to inspection.

TABLE OF CONTENTS (MỤC LỤC):

Contents

About the Editors

Contributors

1. Analytical Techniques for Biopharmaceutical Development

Stephen Tuck

2. Introduction to the Development of Biopharmaceuticals

Roberto Rodriguez-Diaz

3. Protein Assay

Stephen Tuck and Rowena Ng

4. Use of Reversed-Phase Liquid Chromatography in Biopharmaceutical Development

Tim Wehr

5. Practical Strategies for Protein Contaminant Detection by High-Performance Ion-Exchange Chromatography

Pete Gagnon

6. Practical Strategies for Protein Contaminant Detection by High-Performance Hydrophobic Interaction Chromatography

Pete Gagnon

7. Use of Size Exclusion Chromatography in Biopharmaceutical Development

Tim Wehr and Roberto Rodriguez-Diaz

8. Slab Gel Electrophoresis for Protein Analysis

David E. Garfin

9. Capillary Electrophoresis of Biopharmaceutical Proteins

Roberto Rodriguez-Diaz, Stephen Tuck, Rowena Ng, Fiona Haycock, Tim Wehr, and Mingde Zhu

10. Mass Spectrometry for Biopharmaceutical Development

Alain Balland and Claudia Jochheim

11. Analytical Techniques for Biopharmaceutical Development — ELISA

Joanne Rose Layshock

12. Applications of NMR Spectroscopy in Biopharmaceutical Product Development

Yung-Hsiang Kao, Ping Wong, and Martin Vanderlaan

13. Microcalorimetric Approaches to Biopharmaceutical Development

Richard L. Remmele, Jr.

14. Vibrational Spectroscopy in Bioprocess Monitoring

Emil W. Ciurczak

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