Search results for " trends"
Article
FDA Seeks Metrics to Define Drug Quality
Predictive or forecast metrics include maintenance backlogs, complaint trends, internal audits, and the findings of regulatory inspections. Yield analysis or abnormalities of product per batch over ti…
Article
Moving Biosimilars Forward in a Hesitant Market
The biosimilars landscape is growing as market factors, such as pricing pressure, advanced bioprocessing and analytical technologies, and upcoming patent expirations for innovator biologics dr…
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The Smart Benefit of Digital Systems in Preclinical Studies
The advancement of smart drug development reaches far back in the drug development cycle, starting at the R&D phase and moving through the pipeline through to clinical studies. Data gathering…
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Evolving demands of process development services
Over the years and in light of various industry trends, the demands for outsourced services have increased and evolved. In this interview, BioPharm International discusses how process development dema…
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Using Digital Twins to Model Process Chromatography
Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.
By Jennifer Markarian
A digital twin is a model of a proces…
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
Grand View Research, "Gene Therapy Market Size, Share & Trends Analysis," 2019.
2. Markets and Markets, "Gene Therapy Market by Vectors," 2019.
3. F. Masri, E. Cheeseman, and S. Ansorge, Cell …
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Process Development: 2020 Reflections and 2021 Possibilities
The challenges posed by the COVID-19 pandemic in 2020 brought about many unprecedented lessons and promising developments in the biopharmaceutical industry. Last year in particular reenforced the ne…
Article
Reimagining Affordable Biosimilars
Rathore, Trends Biotechnol., 27 (12) 698-705 (2009).
L.M. Friedman, et al., “Introduction to Clinical Trials,” in Fundamentals of Clinical Trials, (Springer, Cham, Switzerland, 5th ed., 2015), …
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Strategizing for Rapid Changeovers in Biologics Manufacturing
“In addition,” he says, “use of analysis of the data collected by the manufacturing execution system can provide information about trends during different changeovers and their possible impacts on the…
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Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
In recent years, the global biopharma industry has seen a rapidly advancing trend toward biotherapeutics or ‘biologic’ drugs—drugs that are produced from living organisms or contain components of li…