Therapeutic Monoclonal Antibodies From Lot Release to Stability Testing

Name: Therapeutic Monoclonal Antibodies
Author: Harleen Kaur

Auteur: Harleen Kaur

Taal: Engels

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Auteur: Harleen Kaur

Engels
Paperback
9780323906005
15 juni 2024
200 pagina's

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Samenvatting

Therapeutic Monoclonal Antibodies and Antibody Drug Conjugates (ADC): 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).

Discusses, in detail, the Lot release methods for both drug substance and drug product, along with their importance in process sample analysis
Gives specific attention to general characteristics tests, such as pH determination, osmolality, sub-visible particle count, appearance and visible tests, and regulatory/pharmacopeial guidelines
Includes different kinds of stability testing (real time, accelerated and stressed) and their importance and determinations on product shelf life
Presents regulatory guidelines on ICH Q2R1, ICHQ6B and ICHQ5C, which are discussed along with analytical method validation, monoclonal antibodies physicochemical characterization and stability testing
Provides different characterization methods and validation and development case studies of monoclonal antibodies, including biosimilars and innovators

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Taal: en
Bindwijze: Paperback
Oorspronkelijke releasedatum: 15 juni 2024
Aantal pagina's: 200

Betrokkenen

Hoofdauteur: Harleen Kaur
Hoofduitgeverij: Academic Press Inc

Overige kenmerken

Product breedte: 152 mm
Product lengte: 229 mm
Studieboek: Nee
Verpakking breedte: 152 mm
Verpakking hoogte: 229 mm
Verpakking lengte: 229 mm
Verpakkingsgewicht: 0 g

EAN

EAN: 9780323906005

Je vindt dit artikel in

Categorieën: Technologie & Bouwkunde

Geneeskunde & Verpleging

Preklinische geneeskunde

Specialistische geneeskunde

Biotechnologie

Farmacologie

Boeken
Taal: Engels
Beschikbaarheid: Te reserveren
Boek, ebook of luisterboek?: Boek
Studieboek of algemeen: Algemene boeken

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