Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing

Erscheinungsjahr 2024
ISBN: 978-0-323-90600-5
Verlag: Elsevier Science & Technology

Buch, Englisch, 200 Seiten, Format (B × H): 229 mm x 167 mm, Gewicht: 290 g

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).

Autoren/Hrsg.

Kaur, Harleen

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Vorklinische Medizin: Grundlagenfächer
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie

Inhaltsverzeichnis

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