Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing

Harleen Kaur (Autor)

Buch | Softcover

174 Seiten

2024
Academic Press Inc (Verlag)
978-0-323-90600-5 (ISBN)

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Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing is a highly topical resource on a subject of interest for scientists and researchers working on monoclonal antibodies' characterization, release testing, stability testing and similarity assessments of monoclonal antibodies in the biopharmaceutical industry. Monoclonal antibodies (mAbs) are large, extremely complex and dynamic biomolecules, so it can be challenging to develop well-characterized therapeutic antibodies that meet regulatory expectations that are also in-line with commercialized standards for different drug markets. Lot release testing and understanding the stability of the mAb over a period of time, and in different environmental conditions, is an indispensable aspect of mAb physicochemical characterization. This book covers the process, including extensive analysis that starts with quantifying the purity attribute to glycan profiling and identifying the mAb primary structure. The book has a primary purpose of focusing on both Lot release testing and stability testing of monoclonal antibodies (subjects not covered in any great detail in other books).

Dr. Harleen Kaur research focuses on the development and characterization of large molecules, particularly monoclonal antibodies (mAbs) and bringing therapeutic molecules from early discovery and research stage to commercialization. Dr Kaur has previously worked for AstraZeneca and WuXi Biologics in the United States and has extensive experience in the development and testing of biologics as therapeutic molecules in a highly regulated environment. She earned her undergraduate degree from Guru Gobind Singh Indraprastha University, India, and PhD degree from the National University of Singapore, Singapore. Dr Kaur is the author of many peer-reviewed publications and book chapters in the area of antibody characterization and aptamers. She is also the lead editor of the book titled “Monoclonal Antibodies: Physicochemical Analysis that was published by Elsevier.

1. General Characteristics
2. Purity analysis
3. N-Linked Oligosaccharide Profiling
4. Identity via Peptide Mapping and cIEF
5. Stability Testing

Erscheinungsdatum	22.08.2024
Verlagsort	Oxford
Sprache	englisch
Maße	152 x 229 mm
Gewicht	290 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
Themenwelt	Technik ► Umwelttechnik / Biotechnologie
ISBN-10	0-323-90600-1 / 0323906001
ISBN-13	978-0-323-90600-5 / 9780323906005
Zustand	Neuware