Search results for " single-use"
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
If they use disposable equipment, such as single-use bioreactors, compatibility of the disposable equipment with the process should also be assessed.
Companies manufacturing only one product use d…
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Taking a “Development-by-Design” Approach to Cell Therapies
Last year, experts at University College, London, attempted to pinpoint the cost and overall economics of allogeneic cell therapy using single-use technologies (2).
What is clear, for both allogen…
Article
Biomanufacturing Outsourcing Globalization Continues
For example, Cytiva built two facilities in China for CMO JHL Biotech, including a KUBio modular biopharma factory in Wuhan that will house 2000-L single-use bioreactors (4). Pall Corp. opened its Lif…
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Quality by Design and Extractable and Leachable Testing
Impact on cell culture might also be important, particularly for single-use fermentation bags, for example, and USP Biological Evaluation, In Vitro (3) would be a reasonable minimal CQA for which to …
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Fermentation for the Future
The 15-mL bioreactor is based on single-use technology and allows up to 48 parallel fermentations. It also integrates with BI’s modular vector technology for optimized cloning and genomic expression. …
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Viral Clearance Challenges in Bioprocessing
Continuous processing
Interest in continuous processing of biologics using single-use systems is gaining traction because this approach can significantly reduce production costs, particularly for s…
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Pharma Investments Reflect Key Industry Trends
Increasing access to single-use technologies for biologics production is further enabling the scale-down of manufacturing facilities, because such systems provide flexibility and enable companies to q…