Search results for " quality"
Article
Virus-like Particles as Therapeutic Moieties of the Future
…h performance liquid chromatography method have been developed as efficient methods for analysis and quality checks of VLPs. These allow quick analysis of VLP assembly for monitoring consistency in V…
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ISPE Releases Cleaning Validation Guide
… its kind in the industry,” said Jose Caraballo, head Audit Program Management Americas, Corporate Quality Audit and Inspections, Bayer US, Guide co-lead, in the press release. “We decided to address…
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Cytiva Invests $500 Million Over 5 Years to Expand Global Capacity
"We know from our customers that availability and lead time are the most important considerations after quality. Cytiva's long-term commitment is to deliver the best product, at the right time, and su…
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Connected, Automated Downstream Process for mAb Screening and Evaluation
…fication set-up, and that it would significantly decrease hands-on time, while assuring that product quality was retained.
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Flexible Facilities for Viral Vector Manufacturing
…L that doubled the site’s laboratory and warehousing capacity for upstream process development and quality control testing of gene therapy products (6). “Logistics and warehousing are vital to the su…
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Introducing Process Characterization Kit: New Tools for Gaining Deeper Chromatography Process Understanding
Study the potential impact of resin ligand density on process outcome with Process Characterization Kits. The kits provide critical insights on resin variation within the ligand density specificatio…
Article
Purification of Plasmid DNA
By switching to modern chromatography resins, Cobra Biologics was able to increase binding capacity and flow rates up to 50% to address the increasing demands for high quality plasmid DNA.
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Five Control Strategy Options to Prevent Resin Variability Impact
Control strategies that assure product quality and process performance are essential in biomanufacturing. Here are the pros and cons of five control strategies that can provide process consist…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
… the following articles were among the most popular published in 2019:
Are You in Control of the Quality of Your mAbs?
Supply Chain Challenges for Single-Use Systems
The Good and Bad of B…
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Risk Assessment: Studying Chromatography Resin Variability
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Many factors can give rise to process variability, such as variation in different process parameters or raw materials. This article focuses on process robu…