Mammalian Cell Cultures for Biologics Manufacturing

ISBN-13: 9783662522707 / Angielski / Miękka / 2016 / 259 str.

Weichang Zhou; Anne Kantardjieff

Opis

Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification.

Spis treści

Mammalian Cell Cultures for Biologics Manufacturing.- Mammalian Cell Line Developments in Speed and Efficiency.- Cell Culture Process Operations for Recombinant Protein Production.- Equipment for Large-Scale Mammalian Cell Culture.- Development and Characterization of a Cell Culture Manufacturing Process Using Quality by Design (QbD) Principles.- Product Quality Considerations for Mammalian Cell Culture Process Development and Manufacturing.- Safety Assurance for Biologics Manufactured in Mammalian Cell Cultures: A Multitiered Strategy.- Mammalian Cell Culture Capacity for Biopharmaceutical Manufacturing.- Transcriptomics as a Tool for Assessing the Scalability of Mammalian Cell Perfusion Systems.- Lifecycle Management for Recombinant Protein Production Using Mammalian Cell Culture Technology.

Blurb

Anne Kantardjieff and Weichang Zhou
Mammalian Cell Cultures for Biologics Manufacturing

Scott Estes and Mark Melville
Mammalian Cell Line Developments in Speed and Efficiency

Susan Abu-Absi, Sen Xu, Hugh Graham, Nimish Dalal, Marcus Boyer and Kedar Dave
Cell Culture Process Operations for Recombinant Protein Production

Sadettin S. Ozturk
Equipment for Large-Scale Mammalian Cell Culture

Daniel M. Marasco, Jinxin Gao, Kristi Griffiths, Christopher Froggatt, Tongtong Wang and Gan Wei
Development and Characterization of a Cell Culture Manufacturing Process Using Quality by Design (QbD) Principles

Michael J. Gramer
Product Quality Considerations for Mammalian Cell Culture Process Development and Manufacturing

Dayue Chen
Safety Assurance for Biologics Manufactured in Mammalian Cell Cultures: A Multitiered Strategy

Dawn M. Ecker and Thomas C. Ransohoff
Mammalian Cell Culture Capacity for Biopharmaceutical Manufacturing

Karthik P. Jayapal and Chetan T. Goudar
Transcriptomics as a Tool for Assessing the Scalability of Mammalian Cell Perfusion Systems

Enda Moran and Patrick Gammell
Lifecycle Management for Recombinant Protein Production Using Mammalian Cell Culture Technology