Search results for " Mab" in Articles / App Notes
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Increasing upstream titers and shrinking development timelines have posed several challenges to downstream process development of mAbs. Some of the major strategies and tools to address these challeng…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
“This characterization should include the determination of physicochemical and immunochemical properties, biological activity, purity, impurities, and quantity of the mAb, in line with ICH Q6B guideli…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
REGULATORY EXPECTATIONS FOR THE ANALYSIS OF MABS
Several guidance documents have been issued by regulatory agencies recommending approaches for protein characterization.3,4 Although guidance docum…
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New Therapies Present Scaling Challenges
In mAb production, increasing production volume to commercial scale is typically a scaling operation. Bioreactor size can be increased (scale up), or the number of bioreactors used can be increased (s…
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Impact of Media Components on CQAs of Monoclonal Antibodies
Of these, mAbs comprise large, multi-domain proteins that require complex machinery for proper protein folding, assembly, and post-translation modifications. These modifications can profoundly affect …
Article
Antibody Production in Microbial Hosts
Therapeutic mAbs and their derivatives—such as antibody fragments (Fab), single-chain Fv (scFv), and diabodies—represent the fastest-growing class of approved therapeutic proteins because of their hig…
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Comparing Protein A Resins for Monoclonal Antibody Purification
As a consequence, downstream processing must accept and handle higher titers of mAbs in harvested cell-culture fluid (HCCF), and vendors of mAb purification technologies must develop chromatography re…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
Different from mAbs
Considering the differences between monoclonal antibody (mAb) production and cell/gene therapy production is also important when establishing a cell/gene therapy facility. Al…
Article
N-Glycan Analysis of Biotherapeutic Proteins
Of these, mAbs represent a large proportion of biotherapeutic glycoproteins and account for approximately half of the biopharmaceutical market, a trend that is set to continue with the advent of biosi…
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Preclinical Evaluation of Product Related Impurities and Variants
The selection of resin, as is known, is guided by the physicochemical properties of the mAb product under investigation. In this case study, the mAb product had the following characteristics: pI, 7.9-…