Search results for "antibody"
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Optimizing Late-Stage and Commercial Cell-Culture Processes
“There is also a renewed interest in non-mammalian cell-based expression systems for manufacturing antibody mimetics and novel scaffolds, for example, and we continue to develop and refine our microbi…
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Challenges in Cell Harvesting Prompt Enhancements
The higher titers and cell densities made the initial clarification of monoclonal antibody (mAb) product more difficult, driving the need for filtration technologies that can handle the large amounts …
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Automation Trend in Fill/Finish Reduces Contamination Risk
Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.
By Feliza Mirasol
Aseptic filling is a crucial process in biopharmaceutical …
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CDMOs Driving Emerging Bio/Pharma Success
…ditional small molecule and monoclonal antibodies being augmented by highly potent small molecules, antibody drug conjugates, and gene and cell therapies
• A favorable regulatory environment t…
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Capacity and Performance of a Next Generation Protein A Chromatography Resin
MabSelect™ PrismA is a protein A resin of which both the ligand and the base matrix have been optimized. The resin exhibits improved capacity over its predecessor MabSelect SuRe™ products, while maint…
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Industry Adoption of Single-Use Systems Remains Low
Abzena, a CDMO, conducts development and GMP manufacture of antibody drug conjugates at its Bristol facility and conducts development and GMP manufacture of monoclonal antibodies and other recombinant…
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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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Platform Technologies Improve Protein Expression
Platform technologies facilitate development and accelerate commercialization of protein therapeutics.
By Cynthia A. Challener
Speed to market is essential in the biopharmaceutica…
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Development of Purification for Challenging Fc-Fusion Proteins
Monoclonal antibody purification processes exist in different well-established platforms with extensive process performance histories for production of commercial mAbs (6-10), which typically consist …