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Focusing on the critical processes of lot release and stability testing, this resource addresses the complexities involved in the characterization of therapeutic monoclonal antibodies (mAbs) within the biopharmaceutical industry. It highlights the challenges of developing well-characterized mAbs that comply with regulatory and commercial standards. Comprehensive analyses, including purity quantification and glycan profiling, are discussed, making it a unique reference for scientists and researchers seeking in-depth knowledge on these essential testing procedures.
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Therapeutic Monoclonal Antibodies - From Lot Release to Stability Testing, Harleen Kaur
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- Année de publication
- 2024
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