Buch, Englisch, 200 Seiten, Format (B × H): 152 mm x 229 mm, Gewicht: 290 g
From Lot Release to Stability Testing
Buch, Englisch, 200 Seiten, Format (B × H): 152 mm x 229 mm, Gewicht: 290 g
ISBN: 978-0-323-90600-5
Verlag: William Andrew Publishing
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).
Fachgebiete
- Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Vorklinische Medizin: Grundlagenfächer
Weitere Infos & Material
1. General Characteristics
2. Purity analysis
3. N-Linked Oligosaccharide Profiling
4. Identity via Peptide Mapping and cIEF
5. Stability Testing
