Search results for " activity"
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
“For structurally more simple biological medicinal products, a comparative clinical efficacy study may not be necessary if similarity of physicochemical characteristics and biological activity or pote…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
The resultant 115 kDa dimeric glycoprotein acts as a soluble receptor for human VEGF, thereby preventing/reducing the biological activity of the latter. Zaltrap is approved for treatment of colorectal…
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A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science.
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…
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A Closer Look at Affinity Ligands
Affinity ligands play an exciting role in the ever-growing sphere of downstream processing. In speaking with BioPharm International®, Phillip Elliott, PhD, associate director of Process Development,…
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Discovering the unknown: How does in silico process development change PD scientists’ work?
In silico process development for chromatography is a paradigm-shifting approach that redefines the routine work of process development scientists. But what does it actually mean to perfor…
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Selecting Chromatography Resins for Bispecific Antibody Purification
Targeting enhancement with two active antibody arms makes bispecific antibodies (bsAbs) highly attractive for the treatment of cancer and other diseases. Their purification can be more challen…
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Digitalization: The Route to Biopharma 4.0
This is an activity that requires extensive human intervention at the moment, partly because of a lack of standards across suppliers of process and analytical equipment. Initiatives such as Internet o…
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High-concentration monoclonal antibody drugs: manufacturing challenges
The growth in the formulation of drugs suitable for delivery by subcutaneous (Sub-C) injection highlights manufacturing challenges associated with the higher concentration of active ingredient…
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Optimization of a two-step purification method for bispecific antibodies
Bispecific antibodies (bsAbs) have gained increasing interest over recent years because they can bind two antigens, offering unique modes of action compared to monoclonal antibodies. New and i…
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Efficient chromatography buffer prep with inline dilution
A typical bioprocess workflow requires many buffers and process liquids in large volumes, making buffer preparation one of the most resource-intensive activities in biomanufacturing facili…