Search results for " efficacy"
Article
Using Software in Process Validation
and requires a team effort that encompasses people from various disciplines within the plant?
It is important to design processes that ensure product quality, safety, and efficacy. Today’s soft…
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Webinar On-Demand: Novel Analytics to Improve Bioprocessing and Validation Guideline
At the recent Biotherapeutics Analytical Summit, Fredrik Sundberg presented the importance of implementation of a robust analytical control strategy to ensure drug product efficacy and patient safet…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
The greatest risks stemming from aggregation are the potential loss of efficacy and immunogenicity in the product.
Not surprisingly, BioPhorum found that aggregation is among the top concerns, alo…
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Science Focus Fuels Successful Process Development for Startups
On the other hand, she notes that the small group was nimble, very focused, had great tenacity, learned quickly, and was able to make great strides in improving the yield, purity, efficacy, and cycle …
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Leveraging Computational Models of Glycosylation for Biopharma QA
Glycosylation impacts the safety and efficacy of protein therapeutics
The following individual glycosylation motifs that are known to influence the safety, pharmacokinetics, and pharmacodynamics o…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Antibodies with slow off rates are often selected as candidates to provide prolonged drug residence time and also potentially higher efficacy (23). A complicating factor in the selection procedures is…
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Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
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CDMOs Driving Emerging Bio/Pharma Success
…hysical products that can be safely and effectively administered to patients, and if that safety and efficacy can be demonstrated in clinical research. For that reason, CDMOs and contract research or…
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Applying GMPs in Stages of Development
…MPs’ should be in place during the later stages of clinical development where the final safety and efficacy of a product are being established. Keep in mind that regardless of the phase of developmen…
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FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
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