Search results for " Protein A"
Article
Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
The typical platform process is generally comprised of an initial capture step with Protein A-chromatography, a first polishing step with cation-exchange media, and a final polishing step using anion-…
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Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like…
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Moving PAT from Concept to Reality
In addition, a variety of on-line tools measure cell density (dielectric spectroscopy, fluorescence spectroscopy); protein aggregates (size-exclusion chromatography and ultra-high-performance liquid c…
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Unifying Continuous Biomanufacturing Operations
Process intensification and the use of high-seed cultures, coupled with continuous methods, allows manufacturers to produce the same quantity of protein as pilot-scale resources in half the time. Benc…
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Single-Domain Antibodies for Brain Targeting
Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.
Smaller recombinant antibody fragments a…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
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Selecting the Right Viral Clearance Technology
It is essential to have an understanding of the protein and its characteristics, according to Kathy Remington, a principal scientist in BioReliance’s Development Services group. “Knowing the protein’s…
Article
Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015
By Anurag S. Rathore, Sumit K. Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Attributes such as residual host-cell proteins, endotoxin, protein aggregates, and biological potency, which may initially be assigned as pCQAs during Phase I development, are highly critical in such …