Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing

Kaur, Harleen

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Book Information
Edition:	1st
Publisher:	Academic Press, Incorporated
ISBN:	0-323-90600-1 (0323906001)
ISBN-13:	978-0-323-90600-5 (9780323906005)
Binding:	Softcover
Weight:	0.00 Lbs.
Pages:	200
Subject Class:	G-S (General Science (Non Medical))
Remarks:	This Title is Not Yet Published, Scheduled to Release 06/15/24
Return Policy:	Returns accepted up to 90 days provided no other recalls or return restrictions apply.

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Abstract:

Monoclonal antibodies (mAbs) are large, extremely complex and dynamic biomolecules and so it can be challenging to develop well-characterised therapeutic antibody meeting various regulatory expectations and commercializing it as a therapeutic drug in different markets. The 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. It includes extensive analysis starting from quantifying the purity attribute to glycan profiling and identification of the mAb primary structure. The purpose of is to specifically focus on both the lot release testing and stability testing of monoclonal antibodies (subjects not covered in any great detail in other books). The book is highly topical, given the great degree of interest by scientists and researchers working on monoclonal antibodies characterisation, release testing, stability testing and similarity assessment of monoclonal antibodies in the biopharmaceutical industry. Discusses, in detail, the LOT release methods for both drug substance and drug product and the importance in process sample analysis Specific attention is given to general characteristics tests such as pH determination, osmolality, sub-visible particle count, appearance and visible tests and regulatory/pharmacoepial guidelines related to each one of them Different kinds of stability testing (real time, accelerated and stressed), their importance and determination of product shelf life are also highlighted Regulatory guidelines such as ICH Q2R1, ICHQ6B and ICHQ5C are discussed and analytical method validation, monoclonal antibodies physicochemical characterization and their stability testing Different characterisation, validation and development case studies of monoclonal antibodies including biosimilars and innovators are specified

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