Search results for " monoclonal" in Articles / App Notes
Article
Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process
A heat-stable exotoxin can remain as a contaminant of a drug substance throughout the whole manufacturing process, with the risk of adversely affecting patients’ health. One such toxin is cereulide …
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Tools and Solutions for Separation of Charged mAb Variants
A biosimilar is an almost identical version of an originator product. To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be …
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3rd BioProcessing Asia Preview: Q&A with John Curling
The 3rd BioProcessing Asia conference will take place November 12-15, 2018 on Langkawi, Malaysia. This week, Bioprocess Development Forum talks with John Curling, Conference Chair, about the upcomin…
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Roadmap Leads to Innovative Biomanufacturing Strategies
The initial emphasis of the Biomanufacturing Technology Roadmap has been on the manufacture of recombinant proteins and, even more specifically, on monoclonal antibodies (mAbs).
With successive …
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Reducing Cross-Contamination Risks in Process Chromatography
Preferred target molecules
A variety of biologics benefit from the use of disposable technology in their production, from monoclonal antibodies (mAbs) and recombinant medicines to vaccines and…
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ADC Development Robust Despite Lackluster Performance
The ADC construct combines a targeted monoclonal antibody (mAb) with a cytotoxic agent, linked together with a stable linker technology. An ADC enables the specific delivery of chemotherapeutics to tu…
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Platform Technologies Improve Protein Expression
Recombinant proteins, peptides, multi-subunit molecules, monoclonal antibodies, fusion proteins, and enzymes are manufactured within a growing plant using sunlight, soil, water, and air as raw materia…
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Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
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The New World of Biopharmaceutical Manufacturing
Companies are implementing end-to-end single-use platforms for monoclonal antibody, antibody drug conjugate, and vaccine production. Flexible facilities are likely to become an important part of large…
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Unifying Continuous Biomanufacturing Operations
included the upstream and preliminary downstream steps of a monoclonal antibody (mAb) in 28 days, with the secondary downstream steps taking an additional two-and-a-half days (3).
A 1998 analysis …