Techniques for Downstream process for Biologic Drugs and Vaccines
- 1st Edition - August 1, 2023
- Imprint: Academic Press
- Author: Basanta Kumara Behera
- Language: English
- Paperback ISBN:9 7 8 - 0 - 4 4 3 - 1 9 1 5 7 - 2
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 1 9 1 5 8 - 9
Techniques for Downstream process for Biologic Drugs and Vaccines provides comprehensive technologies involved in processing postharvest broth to separate the target biologica… Read more
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Request a sales quoteTechniques for Downstream process for Biologic Drugs and Vaccines provides comprehensive technologies involved in processing postharvest broth to separate the target biological therapeutic products of extracellular or intercellular aspects in nature - to its highest purification form, and to thus make it acceptable to end users. The technologies involved in the post-harvesting of fermented broth are explained in this comprehensive resource in a simplified manner with different case studies to help non-engineering students and scientists easily capture the basic principle of biomass processing technologies and their applications in new projects related to the development and manufacturing of therapeutic bio-products.
As conceptual development of biotechnology has taken new shape and style with the integration of medical sciences, physical science, and engineering, and has thus begun the need for the development of microbial or cell line process technology and application for large-scale isolation and purification of metabolites or vaccines through the fermentation process, this book covers the most important aspects.
- Provides insights into the conceptual strategic drive for manufacturing innovative biologically derived therapeutic compounds for commercial purposes
- Focuses on how to execute biopharmaceutical portfolio trends to bring sustainable manufacturing process as per guidelines of international regulatory acts
- Highlights emerging trends in medical sciences on tissue engineering, regenerative medicine, personalized medicines, and various innovative techniques on immunotherapy to fight against life-threatening diseases
students and research in biotechnology, pharmaceutical sciences, medical sciences, biochemical engineering who want to get into depth in the subject and its future prospective to develop biotechnology-based start-up, as an entrepreneur or working in the front-line in biotechnology industries. business communities in biotechnology-based industry for biologic drugs and vaccines production and marketing. Administrators and decision-making bodies to understand the future prospects of biotechnology by going through the global demand of biological drugs in the international market and it value related to GDP of a specific nation
- Cover image
- Title page
- Table of Contents
- Copyright
- About the author
- Chapter 1: Preharvesting conditions and planning for downstream process
- Abstract
- 1.1: Introduction
- 1.2: History of biopharmaceutical development
- 1.3: Biologic, biosimilar, and biobetter
- 1.4: Status of biological product in harvested broth
- 1.5: Status of target bioproduct in the fermented broth
- 1.6: Strategic development of biopharmaceutical production planning
- References
- Chapter 2: Downstream process (harvested broth concentration) phase-I
- Abstract
- 2.1: Downstream processes
- 2.2: Product recovery
- 2.3: Microbial biomass separation
- 2.4: Centrifugation
- 2.5: Flotation
- 2.6: Flocculation
- References
- Chapter 3: Biomass concentrations phase II
- Abstract
- 3.1: Fermented broth concentrations
- 3.2: Evaporation
- 3.3: Methods of feeding of evaporators
- References
- Chapter 4: Release of intracellular materials phase-III
- Abstract
- 4.1: Why disrupt the cell?
- 4.2: Nature of cell boundaries
- 4.3: Response of cell boundary to lysis
- 4.4: Methods for cell lysis (disruption)
- References
- Chapter 5: Extraction of product of interest phase IV
- Abstract
- 5.1: Extraction
- 5.2: Liquid-liquid extraction (LLE)
- 5.3: Reverse micellar system
- 5.4: Supercritical fluid extraction
- 5.5: Microwave-assisted extraction
- 5.6: Membrane filtration (MF)
- 5.7: Chromatography
- 5.8: Formulation and polishing
- 5.9: Integration of different processes for biologic production
- References
- Chapter 6: Viral vectors for vaccine production
- Abstract
- 6.1: Viral vectors for vaccine production
- 6.2: Some important viral vectors
- 6.3: Types of nucleic acids associated with viral vectors
- 6.4: Key properties of viral vectors
- 6.5: Development of viral vectors
- 6.6: Types of vaccines for human use
- 6.7: Next-generation vaccines
- 6.8: Immune system triggering by whole virus
- 6.9: Upstream process for viral vector production
- 6.10: Types of bioreactors used in virus/virus vector culture
- 6.11: Case studies
- References
- Chapter 7: Quality control
- Abstract
- 7.1: Quality control
- 7.2: Types of quality control
- 7.3: Conceptual development of quality control
- 7.4: How to gain consumer’s trust
- 7.5: Tips for identifying & managing project stakeholders
- 7.6: Benefits of quality control and quality assurance
- 7.7: Launching biopharmaceuticals in the market
- 7.8: Validation parameters
- 7.9: Good laboratory practice
- References
- Chapter 8: Quality by design
- Abstract
- 8.1: Qualities by design
- 8.2: Basic of QbD
- 8.3: Benefits of QbD
- 8.4: Significance of QbD
- 8.5: Conceptual development on QbD
- 8.6: Toward QbD
- 8.7: Elements of QbD
- 8.8: How does QbD works?
- 8.9: Control strategy
- 8.10: Challenges
- 8.11: Regulatory aspects to QbD
- 8.12: Process analytical technology
- References
- Chapter 9: Biologic drugs: New frontier
- Abstract
- 9.1: Towards biologics
- 9.2: Biologic production process
- 9.3: What makes biologics unique?
- 9.4: Biologic process for FDA approval
- References
- Chapter 10: Biologics market size, shape and trend
- Abstract
- 10.1: Biologic drugs (biopharmaceuticals) market
- 10.2: Realization of necessity of biologic
- 10.3: Top best-selling biopharmaceuticals for the year 2021
- 10.4: Biologic drug market analysis
- 10.5: Alternate method for saving money on biologics
- 10.6: Biologic market segmentation
- 10.7: Contract manufacturing pharmaceuticals
- References
- Index
- Edition: 1
- Published: August 1, 2023
- Imprint: Academic Press
- No. of pages: 376
- Language: English
- Paperback ISBN: 9780443191572
- eBook ISBN: 9780443191589
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Basanta Kumara Behera
Dr. Basanta Kumara Behera was a Professor of Biotechnology at three distinguished Indian universities, where he taught and conducted research at the post-graduate level on medical biotechnology, biopharmaceutical, microbial process development, drug designing, bio-energy management, and biomass processing technology since 1978. In 2009, he joined an MNC company as an advisor for specialty chemicals production and drug design through microbial process technology. He is associated with national and international companies as a technical advisor to produce biopharmaceuticals under cGMP norms. Dr. Behera has authored and edited books with various publishers worldwide.
Affiliations and expertise
Former Director, Advanced Center for Biotechnology, Maharshi Dayanand University, Rohtak, Haryana, IndiaRead Techniques for Downstream process for Biologic Drugs and Vaccines on ScienceDirect