Biopharmaceutical Manufacturing. Volume 1, Regulatory Processes / Sarfaraz K. Niazi and Sunitha Lokesh.

Format:

Book

Author/Creator:

Niazi, Sarfaraz K., author.

Lokesh, Sunitha, author.

Contributor:

Institute of Physics (Great Britain), publisher.

Series:

IOP ebooks. 2021 collection.

IOP Ebooks Series

Language:

English

Subjects (All):

Biomedical engineering.

Pharmaceutical biotechnology.

Physical Description:

1 online resource (various pagings) : illustrations (some color).

Edition:

First edition.

Other Title:

Regulatory processes.

Place of Publication:

Bristol [England] (Temple Circus, Temple Way, Bristol BS1 6HG, UK) : IOP Publishing, [2021]

System Details:

Mode of access: World Wide Web.

System requirements: Adobe Acrobat Reader, EPUB reader, or Kindle reader.

Biography/History:

Sarfaraz K Niazi is an adjunct professor at the University of Illinois and University of Houston. Prof. Niazi has established numerous consulting businesses and start-up companies within the biopharmaceutical industry, including Pharmaceutical Scientist, Inc and Karyo Biologics, LLC. Sunitha Lokesh is the director of biomanufacturing operations at Pharmaceutical Scientist Inc., where she leads the identification and technology development of biopharmaceutical products.

Summary:

This two-volume set provides a comprehensive guide to the essential aspects of commercial biopharmaceutical manufacturing. Covering the planning, layout and operation of successful commercial manufacturing, the aim of the books is to enable innovations, new drug development, and make affordable biological drugs available to patients worldwide.

Contents:

1. Introduction to biopharmaceuticals

1.1. Overview

1.2. Biopharmaceutical molecules

1.3. Protein structure and properties

1.4. Pharmacokinetic manipulations

1.5. Immunogenicity

1.6. Recombinant expression

1.7. Gene and cell therapy

1.8. Conclusion

2. Antibody biopharmaceuticals

2.1. Overview

2.2. The immune system

2.3. Monoclonal antibodies

2.4. Types of antibodies

2.5. Development of antibodies

2.6. Conclusion

2.7. Databases relevant to antibodies

3. Gene and cell therapy

3.1. Overview

3.2. Gene therapy

3.3. Cell therapy

3.4. Regulatory considerations

3.5. Conclusion

4. Formulation of biopharmaceuticals

4.1. Overview

4.2. Structural instability

4.3. Formulation composition

4.4. Delivery routes

4.5. Formulation technologies

4.6. Examples of formulation

5. Biopharmaceutical development cycle

5.1. Overview

5.2. The US drug development process

5.3. Drug development in Europe

5.4. Japanese drug approval process

5.5. Conclusion

6. Biosimilar biopharmaceuticals

6.1. Overview

6.2. Biosimilarity

6.3. Regulatory guidance

6.4. Development master plan

6.5. Interchangeability and substitution

6.6. Analytical assessment

6.7. Functional assessment

6.8. In vivo assessment

6.9. Clinical pharmacology assessment

6.10. Clinical immunogenicity assessment

6.11. Clinical efficacy assessment

6.12. Extrapolation of clinical data across indications

6.13. Conclusion

7. Intellectual property issues for scientists

7.1. Overview

7.2. Patent law basics

7.3. US patent elements

7.4. Types of patents

7.5. Comparison of patent laws

7.6. Biological patents

7.7. Monoclonal antibody technology

7.8. Antisense technology

7.9. Transgenic plants

7.10. Exclusivities for biological products

7.11. Broad coverage

7.12. The Purple Book

7.13. Patent term extension

7.14. Patent term adjustment

7.15. Freedom-to-operate (FTO) opinions

7.16. Conclusion.

Notes:

"Version: 202112"--Title page verso.

Includes bibliographical references.

Title from PDF title page (viewed on January 18, 2022).

Description based on print version record.

ISBN:

9780750331746

0750331747

9780750331753

0750331755

OCLC:

1291620566