Search results for " attribute"
Article
Reducing Cross-Contamination Risks in Process Chromatography
All of the attributes of single-use technologies--reduced process time, faster equipment turnaround, greater manufacturing flexibility, and reduced risk of cross contamination--apply to chromatography…
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Platform Technologies Improve Protein Expression
“These approaches offer avenues for designing better fit-for-purpose molecules not only in terms of their activity and safety, but also with respect to desirable CMC attributes,” says Voldborg.
Th…
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Development of Purification for Challenging Fc-Fusion Proteins
This high capacity can be attributed to the presence of non-charged groups interspaced within the spacer arm linked to the functional ligand on the resin. HMWs breakthrough was not observed throughout…
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N-Glycan Analysis of Biotherapeutic Proteins
The impact of glycosylation on protein function means that glycosylation can be a critical quality attribute (CQA), making the characterization of N-glycan structures an essential part of the biothera…
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Managing Residual Impurities During Downstream Processing
USP standards for peptides and proteins are undergoing modernization to address the key quality attributes of these products. Test chapters that contain validated methods and associated reference stan…
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Fusion Proteins Pose Manufacturability Challenges
“In particular, the level of N-acetylneuraminic acid or sialylation, which can impact plasma half-life and the potency of the candidate, is a key quality attribute and can be challenging to control wi…
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Downstream Processing for Cell-Based Therapies
As such, manufacturing processes need to be adapted to ensure that the cellular material retains its functionality and the critical quality attributes (CQAs) are maintained throughout the entire proce…
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Single-use Bioreactors Have Reached the Big Time
In fact, an attractive attribute of single-use bioreactors is their full scalability, according to Adams. Today there are systems available for high throughput R&D through to commercial production. Sa…
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
The year ahead is expected to be marked by increased biosimilar development, lower drug prices, and better quality drugs.
The global biopharmaceuticals market was valued at $162 billion in 2014 a…
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Biosimilars to Drive Modern Manufacturing Approaches
OBP Director Steve Kozlowski explained at the Biosimilars Council conference that extensive structural and functional characterization that identifies critical quality attributes, plus adequate clinic…