Search results for " modeling"
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Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling.
By Elizabeth Rivera…
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Remote Monitoring and Big Data Advance Upstream Automation
Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming.
By Cynthia A. Challener
As upstream processing drives toward higher efficiencies in meeti…
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Unifying Continuous Biomanufacturing Operations
Mechanistic modeling may be key for purification processes to be able to react to the inherent variability of cells upstream that result from perfusion, the Karst team demonstrated. Mechanistic modeli…
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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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Preclinical Evaluation of Product Related Impurities and Variants
Fourth, empirical modeling of the resulting data was performed to correlate each of the charged variant to biological activity. Once charge variants that were seen to have statistically significant im…
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Report from the 12th Plasma Product Biotechnology Forum
Mechanistic Modeling
A key role for the conference is of course to present and share how modern technologies can improve efficiency and robustness of plasma fractionation. Takeda’s Paul Sylvain…
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Maximum Output Starts with Optimized Upstream Processing
Samsung, for example, is leveraging automation, ultra scale-down modeling in microreactors, in-silico and predictive modeling including metabolomics, and mobile apps for company-wide data visibility t…
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QbD Improves Cell-Culture Process Control
However, using a quality-by-design (QbD) approach that employs predictive modeling can improve the quality of end product as well as the efficiency of the bioprocess.
Real-time quality control
…
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Being Thorough When Transferring Technology
This can be met with qualified scale-down models or modeling. Successful scale-up that matches predicted behavior demonstrates good process understanding. This can help in justifying fewer as opposed …
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Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict.
By Randi Hernandez
Demand for any given new product is typically only known after significant investments h…