Search results for " analytical"
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Meeting the Process Development Challenges of a Diverse Biologic Pipeline
While these novel biologics are filling drug pipelines, they are also challenging existing manufacturing processes in upstream, downstream, and analytical development.
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Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
The implementation of advanced process analytical technologies (PAT), especially online real-time monitoring could further accelerate the roll-out of mechanistic modeling in the biopharmaceutical indu…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Continuing innovations in single-use technologies, process analytical technologies, and in-line dilution will offer the potential for further significant benefits in the future.
Acknowledgments
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Understanding and Controlling Raw Material Variation in Cell Culture Media
Manage variability through advanced analytical methods and risk-based assessment.
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The Need for Advanced Process Modeling for New Therapeutic Biologics
The Need for Advanced Process Modeling for New Therapeutic BiologicsThe trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling e…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
Despite acknowledgment of how valuable process analytical technology (PAT) is to various biomanufacturing processes, the industry has been somewhat slow to adopt PAT-focused platforms and services for…
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Legal experts in biopharmaceutical patent law shed some light on trends and recent news.
By Agnes Shanley
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Using Software in Process Validation
Software systems have become instrumental as validation expands from analytical methods used for the quality control of drug substances and drug products to computerized systems for clinical trials, l…
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Best Practices for Selecting a Top-Quality Cell Line
“We work closely with our analytical and process development teams to ensure the developability, monoclonality, and scalability of our cell lines and to achieve the key product quality attributes that…