Search results for " Mab"
Article
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 …
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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…
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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-…
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Process Chromatography: Continuous Optimization
Generally for mAbs, both strong CEX and AEX resins are preferred, according to Shelly Parra, global field applications senior manager with Thermo Fisher Scientific.
Mixed-mode and multi-mode resin…
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QbD and PAT in Upstream and Downstream Processing
It is important to note that mAbs are currently the leading area of biopharmaceutical research. One of the key parameters to monitor in the implementation of QbD in mAb production is the glycosylation…
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Advances in Engineering of Protein-Based APIs
Peptides and peptidomimetic therapeutics offer the advantages of mAbs but in smaller molecules that may be formulated for oral delivery.
Advanced modeling tools are enabling the rapid engineerin…