The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics (Record no. 44758)
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| fixed length control field | 04724nam a22004577a 4500 |
| 001 - CONTROL NUMBER | |
| control field | sulb-eb0022666 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | BD-SySUS |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20160413122312.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 130507s2013 xxu| s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781461469162 |
| -- | 978-1-4614-6916-2 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1007/978-1-4614-6916-2 |
| Source of number or code | doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RS380 |
| Classification number | RS190-210 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | TDCW |
| Source | bicssc |
| Subject category code | MED072000 |
| Source | bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.19 |
| Edition number | 23 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Geigert, John. |
| Relator term | author. |
| 245 14 - TITLE STATEMENT | |
| Title | The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics |
| Medium | [electronic resource] / |
| Statement of responsibility, etc. | by John Geigert. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 2nd ed. 2013. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | New York, NY : |
| Name of producer, publisher, distributor, manufacturer | Springer New York : |
| -- | Imprint: Springer, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2013. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | XXIX, 338 p. 24 illus., 17 illus. in color. |
| Other physical details | online resource. |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Media type code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Carrier type code | cr |
| Source | rdacarrier |
| 347 ## - DIGITAL FILE CHARACTERISTICS | |
| File type | text file |
| Encoding format | |
| Source | rda |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Complexity of Biologica CMC Regulation -- Biologics are Not Chemical Drugs -- An Effective CMC Strategy is Possible -- Challenge of Adventitious Agent Control -- Source Materials for Biologics -- Manufacture of the Biologic API -- The Biologic Final Product Process -- Complex Process-Related Impurities -- Molecular Structural Analysis -- Functional Activity (Potency) -- Setting Specifications and Expiry Dates -- Demonstrating Product Comparability -- CMC-Focused Regulatory Meetings -- References. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | An effective CMC regulatory compliance strategy for biologics and biopharmaceuticals can seem like a mystery. Through means of this 2nd edition, this no longer needs to occur. A great deal of thanks goes to two regulatory authorities – the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), who provide through their respective websites, an abundance of guidance, especially in the last several years. So much has changed since the 1st edition of this book was published in 2004. There are now additional manufacturing processes for producing commercial biopharmaceuticals – transgenic plant cell cultures and transgenic animals. In addition to commercial recombinant proteins and monoclonal antibodies, there are now commercial cell-based medicines (cellular therapy) and DNA-based medicines (gene therapy). Biosimilars are now on the marketplace in Europe, and under review for commercial approval in the USA. Vaccine manufacturing has resurged due to the concerns of potentially pandemic mutated animal influenzas (e.g., swine flu, bird flu). Strategic international regulatory guidances have been adopted that are driving the entire pharmaceutical industry, including biopharmaceuticals, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality Systems (PQS). The vast majority of the over 600 regulatory references listed in this book were either issued or updated since the release of the 1st edition. All of these changes are the reason this updated edition includes not only biopharmaceuticals but also other biologics (e.g., live virus vaccines, human plasma-derived proteins, cell-based medicines, natural-sourced proteins) that have CMC regulatory compliance concerns and challenges in common with the genetically-engineered biologics (i.e., the biopharmaceuticals). About The Author John Geigert is President of BioPharmaceutical Quality Solutions, which specializes in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry. Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry. Dr. Geigert has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board and served as an expert member of the USP Biotechnology Committee. Dr. Geigert has written extensively for the Regulatory Affairs Professional Society (RAPS) Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series) and Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series)). |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medicine. |
| Topical term or geographic name as entry element | Pharmaceutical technology. |
| Topical term or geographic name as entry element | Biomedicine. |
| Topical term or geographic name as entry element | Pharmaceutical Sciences/Technology. |
| Topical term or geographic name as entry element | Biomedicine general. |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY | |
| Title | Springer eBooks |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Printed edition: |
| International Standard Book Number | 9781461469155 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="http://dx.doi.org/10.1007/978-1-4614-6916-2">http://dx.doi.org/10.1007/978-1-4614-6916-2</a> |
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| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
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