Search results for " Mabs" 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…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
…pping are routinely used to assess and compare the protein backbone of the light and heavy chains of mAbs (10, 11) and can be valuable tools in determining product CQAs. Intact molecular weight analy…
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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 addition, mammalian cell culture technology has advanced such that producing multi-kilogram quantities of therapeutic mAbs in one batch is now commonplace (1). With a cell therapy, however, establi…
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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 reversible nature of the modifications that result in the charge heterogeneity of mAbs (particularly that of acidic variants) makes them susceptible to changes over the course of storage. This nec…