Chapter title |
Lifecycle Management for Recombinant Protein Production Using Mammalian Cell Culture Technology.
|
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Chapter number | 258 |
Book title |
Mammalian Cell Cultures for Biologics Manufacturing
|
Published in |
Advances in biochemical engineering biotechnology, November 2013
|
DOI | 10.1007/10_2013_258 |
Pubmed ID | |
Book ISBNs |
978-3-64-254049-3, 978-3-64-254050-9
|
Authors |
Moran E, Gammell P, Enda Moran, Patrick Gammell, Moran, Enda, Gammell, Patrick |
Abstract |
Product lifecycle management refers to the oversight process and activities carried out to fully realize the commercial potential and value of a product in the marketplace. It is typical for many changes to be introduced to the production processes and testing methods for biopharmaceutical drugs over their lifetime in the commercial marketplace. Technology lifecycle management, as discussed here, refers to the management of the different phases or generations of processes and methods used to make and test the active biopharmaceutical ingredient or drug product, and the adoption of different devices used to present the drug product to patients. The factors to consider when making changes to a commercial biopharmaceutical manufacturing process as part of a technology lifecycle management program are discussed. A case study outlines one approach taken in bringing forward a major process change to a cell culture process for the production of a therapeutic recombinant protein. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 12 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 3 | 25% |
Student > Ph. D. Student | 3 | 25% |
Student > Doctoral Student | 1 | 8% |
Student > Bachelor | 1 | 8% |
Lecturer > Senior Lecturer | 1 | 8% |
Other | 3 | 25% |
Readers by discipline | Count | As % |
---|---|---|
Engineering | 4 | 33% |
Agricultural and Biological Sciences | 3 | 25% |
Medicine and Dentistry | 2 | 17% |
Nursing and Health Professions | 1 | 8% |
Pharmacology, Toxicology and Pharmaceutical Science | 1 | 8% |
Other | 1 | 8% |