Search results for " clinical trials" in Articles / App Notes
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
This approach will require additional effort to demonstrate comparability between the early-phase and commercial product, which potentially creates a risk of the need for additional clinical trials. A…
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Reimagining Affordable Biosimilars
Costs range from approximately $500 million to $3 billion, and development takes more than a decade, the majority of which is required for clinical trials (2,3). While effective and successful, biothe…
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mAbs to Watch in 2016
In clinical trials, ixekizumab demonstrated superiority over Enbrel (etanercept) for clearing skin plaques.
Brodalumab—Valeant and AstraZeneca’s IL-17 therapy, brodalumab, for the treatment of pso…
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ADC Development Robust Despite Lackluster Performance
Optimism in the pipeline
Despite the promise of ADCs as an alternative therapeutic for cancers, response rates to these drugs in clinical trials have been typically low, and in addition, toxicity …
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Science Focus Fuels Successful Process Development for Startups
… its novel therapeutics (both drug substance and drug products), in the design and implementation of clinical trials, and in the selection of new drug targets.
In the context of cell therapies, p…
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The Affordable Care Act's Impact on Innovation in Biopharma
The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.
The Affordable Care Act (ACA) has elicited intense national debate and sent biopharm…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
…her-order structures, animal models, simulation tools and complex algorithms, expertise in designing clinical trials that target the appropriate end points and do so with as few patients and as quick…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
A broad range of alternative BioTx modalities have obtained regulatory approval and are currently in clinical trials (17–21) including antibody fragments, single-domain mAbs, Fc-fusions, vaccines, ant…
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Genetic Vaccine Platforms Demonstrate Their Potential
“Opportunities to increase stability that involve substantial revision of the final formulation may require additional and extensive clinical trials to establish efficacy and safety along with revalid…
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Can Vaccine Development Be Safely Accelerated?
The goal is to complete preclinical development within 16 weeks and then progress directly to Phase I clinical trials, with completion of that step in 10 weeks, followed by large-scale production of m…