Search results for " industry"
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Technology Innovations Improve Process Chromatography Performance
Current challenges
The biopharmaceutical industry continues to face technical and logistical challenges in process chromatography, particularly during scale-up. Although significant work has been …
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
How do you believe mechanistic modeling in process development will develop in the future?
Mechanistic models are already considered being a game changer for the industry and their applications wi…
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Together, these trends have the potential to transform the industry, but advances in both instrumentation and lab informatics are needed before the full benefits can be realized.
With the exceptio…
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A Plastic Pipeline for Commercial Bioprocessing?
Adoption for commercial production has been slow; however, as more therapies developed under single-use processes move toward regulatory approval, industry experts expect the percentage of biologic-ba…
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Ensuring Viral Safety of Viral Vaccines and Vectors
HTST is commonly used in the food and beverage industry for high-volume processing. A liquid is heated and held at 102 °C for at least 10 seconds, then cooled to 37 °C before being sent to the bioreac…
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Establishment of New Modern Plasma Fractionation Facilities in Asia
Plasma fractionation is sometimes considered as a conservative industry and less open to changes. Do you agree?
The plasma fractionation industry has often been regarded as a curiosity or an ana…
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Leveraging Data for Better Biopharmaceutical Process Control
Recently, there has been a significant mindset change in the industry. Biopharmaceutical companies are starting to use PAT in more advanced development and even some manufacturing work, while methods …
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Managing Residual Impurities During Downstream Processing
There are several implications of these documents, according to Wake, but on a practical level they require industry to replace traditional wet chemistry techniques for heavy-metal determination with …
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Mechanistic Modeling of Preparative Ion-Exchange Chromatography
DOE-based approaches dominate modeling efforts in industry and can be quite effective at offering process knowledge and determining the design space. However, because they do not incorporate the under…
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Drug Quality Key to Innovation and Access
In late November 2016, FDA revised a July 2015 proposal to address industry concerns about the scope and objectives of this quality metrics data submission initiative (1).
Under the new draft guid…