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Therapeutic Monoclonal Antibodies - From Lot Release to Stability Testing (Paperback)
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Therapeutic Monoclonal Antibodies - From Lot Release to Stability Testing (Paperback)
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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).
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