Search results for "Mab"
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
FDA approved the first Humira (adalimumab) biosimilar, Amjevita (Amgen), in September 2016, and it was the fourth biosimilar approved in the United States. The European Medicines Agency (EMA) started …
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Ligand-Binding Assays and the Determination of Biosimilarity
For monoclonal antibodies (mAbs), which make up a large portion of the biosimilars currently under development, it is important to remember that the different ends of the molecule are involved in bind…
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Single-Domain Antibodies for Brain Targeting
Going single domain
Biologic therapies such as monoclonal antibodies (mAbs) are enabling the targeted, personalized treatment of cancer, inflammatory diseases, infectious diseases, and diseases of…
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Digitalization: The Route to Biopharma 4.0
In the biopharma industry, distributed control system (DCS) and programmable logic controller (PLC) with SCADA system are two of the commonly used automation platforms. DCS has centralized set point m…
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As the therapeutic pipeline diversifies, chromatography toolboxes are expanding.
For traditional mAbs, protein A chromatography is used to capture antibodies. Depending on the structure of the target antibody and the impurity profile, other affinities, like protein L or variants o…
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Top Process Development Trends for 2021 and a Look into 2022
…here has been a significant increase in titers of bioprocess, especially for monoclonal antibodies (mAbs). In the 1980s and 1990s, mAb titers were only 0.5 g/L. From the 1990s onward, the average mAb…
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Updating Viral Clearance for New Biologic Modalities
For traditional downstream processing templates, such as monoclonal antibody (mAb) purification, the technologies used to ensure virus removal are well established and their effectiveness has been con…
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Process Development: 2020 Reflections and 2021 Possibilities
…ctive production of therapeutics is process chromatography, particularly for monoclonal antibodies (mAb) and gene therapies. This makes knowing the current status of process chromatography and what t…
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Reimagining Affordable Biosimilars
Advances in preclinical development
Analytics
The complexity of biotherapeutic molecules, in particular monoclonal antibodies (mAbs), lends themselves to fascinating targets for analytical…
Article
Flexible Facilities for Viral Vector Manufacturing
While the initial project looked at a monoclonal antibody (mAb) facility, the team plans to extend the concept to cell and gene therapy production.
Cytiva has amassed expertise in modular design a…