Search results for " analytical"
Article
Genetic Vaccine Platforms Demonstrate Their Potential
However, for genetic vaccines, this means developing a whole new battery of analytical methods, especially around purity and potency,” Christy states. “Methods exist, but these generally are research-…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com
By Cynthia A. Challener
Facility and equipment design are important, but the team and its experience matter most.
Through its Operation Warp Speed pro…
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Gene Therapies Push Viral Vector Production
Another manufacturing challenge in viral vector production, Murphy points out, is the development and qualification of robust analytical methods to measure product quality.
“At the present time…
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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…
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Cell-Culture Advances Test Bioreactor Performance Models
Role of process analytical technology
Useful models must be robustly validated with real data. The greater the amount of good data incorporated into a model, the more insight the model can provi…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
What’s more, analytical platforms for in-process control and cell characterization are lacking in the cell therapy industry but are being actively pursued.”
It is important to note, however, whe…
Article
What’s New in Upstream Technologies
Both the sensor and the sensor adapter operate with the company’s Rosemount liquid analytical 56 transmitter. Additionally, the new sensor technologies and the transmitter are fully compatible with th…
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Cytiva Announces Digital Collaboration with Amgen To Improve Biomanufacturing Performance Reliability
Cytiva announced a digital data exchange collaboration program with Amgen, which will include advanced data analytics to increase the understanding of the relationship between raw material variability…
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Biopharma Says It Has an Evolution in New Technologies and Processes
Technologies such as machine learning, big data, process analytical technology, and automation can assist in the move to performance-based regulation.
FDA has been actively encouraging drug manufa…
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
But, you must have the right analytical tools to understand what you're making and whether that’s meaningful from a clinical standpoint or not.
How could one overcome these challenges?
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