東華大學圖書館 |

Language: English

Help

回圖書館首頁

手機版館藏查詢

Back

Switch To: Labeled | MARC Mode | ISBD

The challenge of CMC regulatory comp...

Geigert, J.

Linked to FindBook

Google Book

Amazon

博客來

The challenge of CMC regulatory compliance for biopharmaceuticals

Record Type:	Electronic resources : Monograph/item
Title/Author:	The challenge of CMC regulatory compliance for biopharmaceuticals/ by John Geigert.
Author:	Geigert, J.
Published:	Cham :Springer Nature Switzerland : : 2023.,
Description:	xxxv, 573 p. :ill., digital ;24 cm.
[NT 15003449]:	Biopharmaceutical Landscape -- Regulatory Pathways Impacting Biopharmaceuticals -- Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs -- Risk Management of the Minimum CMC Regulatory Compliance Continuum -- Ever-Present Threat of Adventitious Agent Contamination -- Starting Materials for Manufacturing the Biopharmaceutical Drug Substance -- Upstream Production of the Biopharmaceutical Drug Substance -- Downstream Purification of the Biopharmaceutical Drug Substance -- Manufacturing the Biopharmaceutical Drug Product -- Complex Process-Related Impurity Profiles -- Seemingly Endless Biomolecular Structural Variants -- Indispensable Potency (Biological Activity) -- Biopharmaceutical Critical Quality Attributes -- The Art of Setting Biopharmaceutical Specifications - Release and Shelf-Life -- The Challenge of Demonstrating Biopharmaceutical Product Comparability -- Strategic CMC-Focused Interactions with Regulatory Authorities.
Contained By:	Springer Nature eBook
Subject:	Pharmaceutical biotechnology industry - Law and legislation. -
Online resource:	https://doi.org/10.1007/978-3-031-31909-9
ISBN:	9783031319099

The challenge of CMC regulatory compliance for biopharmaceuticals
Geigert, J.

The challenge of CMC regulatory compliance for biopharmaceuticals[electronic resource] /by John Geigert. - Fourth edition. - Cham :Springer Nature Switzerland :2023. - xxxv, 573 p. :ill., digital ;24 cm.

Biopharmaceutical Landscape -- Regulatory Pathways Impacting Biopharmaceuticals -- Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs -- Risk Management of the Minimum CMC Regulatory Compliance Continuum -- Ever-Present Threat of Adventitious Agent Contamination -- Starting Materials for Manufacturing the Biopharmaceutical Drug Substance -- Upstream Production of the Biopharmaceutical Drug Substance -- Downstream Purification of the Biopharmaceutical Drug Substance -- Manufacturing the Biopharmaceutical Drug Product -- Complex Process-Related Impurity Profiles -- Seemingly Endless Biomolecular Structural Variants -- Indispensable Potency (Biological Activity) -- Biopharmaceutical Critical Quality Attributes -- The Art of Setting Biopharmaceutical Specifications - Release and Shelf-Life -- The Challenge of Demonstrating Biopharmaceutical Product Comparability -- Strategic CMC-Focused Interactions with Regulatory Authorities.

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 in can 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.

ISBN: 9783031319099

Standard No.: 10.1007/978-3-031-31909-9doiSubjects--Topical Terms:

3410207
Pharmaceutical biotechnology industry
--Law and legislation.

LC Class. No.: RS380 / .G45 2023

Dewey Class. No.: 615.19

The challenge of CMC regulatory compliance for biopharmaceuticals
LDR:03378nmm a2200337 a 4500 001 2318375
003 DE-He213
005 20230615105203.0
006 m d
007 cr nn 008maaau
008 230902s2023 sz s 0 eng d
020 $a 9783031319099 $q (electronic bk.)
020 $a 9783031319082 $q (paper)
024 7 $a 10.1007/978-3-031-31909-9 $2 doi
035 $a 978-3-031-31909-9
040 $a GP $c GP
041 0 $a eng
050 4 $a RS380 $b .G45 2023
072 7 $a TCB $2 bicssc
072 7 $a SCI010000 $2 bisacsh
072 7 $a TCB $2 thema
082 0 4 $a 615.19 $2 23
090 $a RS380 $b .G312 2023
100 1 $a Geigert, J. $3 3633338
245 1 4 $a The challenge of CMC regulatory compliance for biopharmaceuticals $h [electronic resource] / $c by John Geigert.
250 $a Fourth edition.
260 $a Cham : $b Springer Nature Switzerland : $b Imprint: Springer, $c 2023.
300 $a xxxv, 573 p. : $b ill., digital ; $c 24 cm.
505 0 $a Biopharmaceutical Landscape -- Regulatory Pathways Impacting Biopharmaceuticals -- Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs -- Risk Management of the Minimum CMC Regulatory Compliance Continuum -- Ever-Present Threat of Adventitious Agent Contamination -- Starting Materials for Manufacturing the Biopharmaceutical Drug Substance -- Upstream Production of the Biopharmaceutical Drug Substance -- Downstream Purification of the Biopharmaceutical Drug Substance -- Manufacturing the Biopharmaceutical Drug Product -- Complex Process-Related Impurity Profiles -- Seemingly Endless Biomolecular Structural Variants -- Indispensable Potency (Biological Activity) -- Biopharmaceutical Critical Quality Attributes -- The Art of Setting Biopharmaceutical Specifications - Release and Shelf-Life -- The Challenge of Demonstrating Biopharmaceutical Product Comparability -- Strategic CMC-Focused Interactions with Regulatory Authorities.
520 $a 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 in can 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.
650 0 $a Pharmaceutical biotechnology industry $x Law and legislation. $3 3410207
650 0 $a Pharmaceutical biotechnology $x Quality control. $3 916642
650 1 4 $a Biologics. $3 3633339
650 2 4 $a Pharmaceutics. $3 3538434
650 2 4 $a Pharmacy. $3 636101
710 2 $a SpringerLink (Online service) $3 836513
773 0 $t Springer Nature eBook
856 4 0 $u https://doi.org/10.1007/978-3-031-31909-9
950 $a Biomedical and Life Sciences (SpringerNature-11642)