Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing by Harleen Kaur

Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing by Harleen Kaur

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.

SKU	Unavailable
ISBN 13	9780323906005
ISBN 10	0323906001
Title	Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing
Author	Harleen Kaur
Condition	Unavailable
Binding Type	Paperback
Publisher	Elsevier Science & Technology
Year published	2024-06-13
Number of pages	174
Cover note	Book picture is for illustrative purposes only, actual binding, cover or edition may vary.