Search results for " investments" in Articles / App Notes
Article
Improving Upstream Predictability
Better understanding and control of cell behavior is yielding benefits, upstream and beyond.
By Agnes Shanley
In the earliest days of biotech, developers often struggled to sust…
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Although the industry as a whole has been slow to adopt these techniques, FDA actively encourages continuous production, and companies such as Sanofi and WuXi Biologics have made significant investmen…
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Monitoring and Control of Inline Dilution Processes
Eventually, by getting more out from their existing facilities, biomanufacturers can avoid or delay substantial capital investments,” she states.
In addition to freeing up space, optimizing labor,…
Article
Tools and Processes for Mature and Emerging Therapies
Backing from the investment community in innovator companies and investments by major contract development and manufacturing organizations in cell and gene therapy capacity are strong indicators the b…
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Moving PAT from Concept to Reality
Drug companies would like to start manufacturing process development later in the overall development cycle—preferably during Phase III of clinical trials—in order to focus their investments on candid…
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FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
Ibreakstock/Shutterstock.co…
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
An interview with Aaron Noyes, Head of Downstream Processing at Codiak BioSciences
Some therapeutic targets have long frustrated drug developers hoping to crack the code of mitigating un…
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Roadmap Leads to Innovative Biomanufacturing Strategies
Future facilities will need to accommodate an increasingly wider array of product types to justify the significant capital investments associated with manufacturing capacity.
It is also importan…
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Best Practices for Data Integrity
These investments usually occur in the form of additional manual document reviews, more rigorous quality documentation, hiring more personnel, implementing electronic systems, and so on.
…
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Managing Residual Impurities During Downstream Processing
Intertek has also made investments in capital and personnel to ensure that it can offer optimal solutions for elemental analysis according to ICH Q3D requirements. “Certainly, this area is one in whic…