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14 produkter

Challenge of CMC Regulatory Compliance for Biopharmaceuticals
AvJohn Geigert
Inbunden, Engelska, 2026
2 018 kr
Skickas inom 10-15 vardagar
CMC regulatory compliance strategy for biopharmaceuticals has become vastly more complex and challenging in the past couple of years, especially as the number of gene therapies have entered development and even market approval. Biopharmaceuticals today can be either protein-based or gene-based. For gene-based biopharmaceuticals, the CMC regulatory compliance strategy must address adequate controls and patient safety concerns for viral vectors, non-viral vectors and genetically modified patient cells. Regulatory authorities, primarily the U.S. FDA and the European EMA, have responded to this increasing CMC regulatory compliance complexity of biopharmaceuticals, and have issued over 150 new or updated regulatory guidelines since the publishing of the previous edition. This book covers effective, risk-based, and current, CMC regulatory compliance strategies for biopharmaceuticals. In this 5th edition, updates include new information on source material control in the manufacturing of biopharmaceutical drug substances, critical process controls in the manufacturing of biopharmaceutical drug substances, and more. This book is intended for biopharmaceutical professionals.
Challenge of CMC Regulatory Compliance for Biopharmaceuticals
AvJohn Geigert
Inbunden, Engelska, 2003
2 002 kr
Skickas inom 10-15 vardagar
"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed.
Challenge of CMC Regulatory Compliance for Biopharmaceuticals
AvJohn Geigert
E-bok
PDF, Engelska, 2012
2 917 kr
Läs direkt efter köp
"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed.
Challenge of CMC Regulatory Compliance for Biopharmaceuticals
AvJohn Geigert
Häftad, Engelska, 2012
2 242 kr
Skickas inom 10-15 vardagar
"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed.
Challenge of CMC Regulatory Compliance for Biopharmaceuticals
AvJohn Geigert
Inbunden, Engelska, 2013
2 800 kr
Skickas inom 10-15 vardagar
This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)
Challenge of CMC Regulatory Compliance for Biopharmaceuticals
AvJohn Geigert
E-bok
PDF, Engelska, 2014
2 599 kr
Läs direkt efter köp
This book highlights the challenges facing quality assurance/quality control (QA/QC) in today''s biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)
Challenge of CMC Regulatory Compliance for Biopharmaceuticals
AvJohn Geigert
Häftad, Engelska, 2016
2 018 kr
Skickas inom 10-15 vardagar
This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)
Challenge of CMC Regulatory Compliance for Biopharmaceuticals
AvJohn Geigert
Inbunden, Engelska, 2019
1 795 kr
Skickas inom 10-15 vardagar
Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
Challenge of CMC Regulatory Compliance for Biopharmaceuticals
AvJohn Geigert
E-bok
Engelska, 2019
2 267 kr
Läs direkt efter köp
Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
Challenge of CMC Regulatory Compliance for Biopharmaceuticals
AvJohn Geigert
Inbunden, Engelska, 2023
2 459 kr
Skickas inom 5-8 vardagar
Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but incan readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book:Updates real-world CMC deficiency examples with current examples;Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance;Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
Challenge of CMC Regulatory Compliance for Biopharmaceuticals
AvJohn Geigert
E-bok
Engelska, 2023
2 267 kr
Läs direkt efter köp
Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition.
Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but incan readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval.
In summary, this book:
Updates real-world CMC deficiency examples with current examples;Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance;Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
AvJohn Geigert
Engelska, 2023
665 kr
Skickas inom 5-8 vardagar
Challenge of CMC Regulatory Compliance for Biopharmaceuticals
AvJohn Geigert
Häftad, Engelska, 2024
1 795 kr
Skickas inom 10-15 vardagar
Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but incan readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book:Updates real-world CMC deficiency examples with current examples;Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance;Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
Challenge of CMC Regulatory Compliance for Biopharmaceuticals
AvJohn Geigert
E-bok
Engelska, 2026
2 043 kr
Läs direkt efter köp
CMC regulatory compliance strategy for biopharmaceuticals has become vastly more complex and challenging in the past couple of years, especially as the number of gene therapies have entered development and even market approval. Biopharmaceuticals today can be either protein-based or gene-based. For gene-based biopharmaceuticals, the CMC regulatory compliance strategy must address adequate controls and patient safety concerns for viral vectors, non-viral vectors and genetically modified patient cells. Regulatory authorities, primarily the U.S. FDA and the European EMA, have responded to this increasing CMC regulatory compliance complexity of biopharmaceuticals, and have issued over 150 new or updated regulatory guidelines since the publishing of the previous edition. This book covers effective, risk-based, and current, CMC regulatory compliance strategies for biopharmaceuticals. In this 5th edition, updates include new information on source material control in the manufacturing of biopharmaceutical drug substances, critical process controls in the manufacturing of biopharmaceutical drug substances, and more. This book is intended for biopharmaceutical professionals.

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John Geigert – författare

Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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