Search results for " efficacy"
Article
Tackling Analytical Method Development for ADCs
…ocess knowledge support the idea that manufacturing and analysis of ADCs with consistent quality and efficacy is achievable, according to Kaur. He also notes that with the move to adopt a quality-by-…
Article
Fermentation for the Future
In yeast, N-glycosylation does not occur in the same manner as it does in humans, which can affect the efficacy of the therapeutic protein. Therefore, genetic engineering of P. pastoris was pursued to…
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Ligand-Binding Assays and the Determination of Biosimilarity
During biosimilar development, it is necessary to demonstrate that the physicochemical properties, efficacy, and safety (e.g., immunogenicity) of the biosimilar are similar to those of the …
Article
What Drove Biopharma Development in 2014?
…pproval changes, streamline data flows across the entire life cycle of the drug, and improve overall efficacy and cost-efficacy for patients and manufacturers. So, it is no surprise that half of the …
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Securing the Single-Use Supply Chain
“To achieve dual sourcing, one must have documented evidence that a change in input (product contact materials) will not affect the output (product quality, efficacy, safety), and it is ultimately thr…
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Improving PAT for Biologics
“MVDA techniques are being increasingly used for scale- and batch-to-batch comparison investigations to support or derive process understanding and to ultimately improve the quality, safety, and effic…
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Challenges and Trends in Biopharma Facility Design
This involves many aspects, from market as well as scientific and technological perspectives including:
• Product efficacy and approval--will it at all get to market?
• Market demand
• Siz…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Third is increased focus on relating the quality attributes of a biotech product to its clinical safety and efficacy. Fourth is the extension of the QbD concepts from the traditional process developme…
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Single-Domain Antibodies for Brain Targeting
The fusion of an Albu/Ab to interleukin-1 receptor antagonist (AlbudAb/IL-1ra) resulted in improved in-vivo efficacy due to its extended serum half-life (29). AlbuAbs could be used to generate a range…
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Analyzing Proteins Using SEC, MALS, and UHPLC
Thus, even at low levels, their presence can lead to antibody production against the drug, resulting in more rapid clearance and lower efficacy, and at higher levels, anaphylaxis,” he explains.
In…