Search results for " process" in Articles / App Notes
Article
HTPD: Optimizing a mAb Chromatography Polishing Step
In addition, steadily increasing demands from regulatory authorities for better understanding and control of manufacturing processes put even more pressure on development work. High-throughput process…
Article
The Metrics of Quality Culture
Specifically, Title VII Section 705 of the Act states FDA “shall inspect establishments described in paragraph [1] that are engaged in the manufacture, preparation, propagation, compounding, or proces…
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Quality Systems Key to Lifecycle Drug Management
… over the past decade, partly due to the practice of “locking in” an applicant’s manufacturing process before it is fully optimized. Field inspection is not connected to knowledge gained from product…
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Biomanufacturing Outsourcing Globalization Continues
A solid majority of biologics developers indicated in the 2015 study that they will not offshore any of their process development for biomanufacturing over that period, a result that is consistent wit…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
Protein aggregation can occur during all stages of the lifetime of a protein therapeutic, including expression, refolding, purification, sterilization, shipping, storage, and delivery processes (1). T…
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Fermentation for the Future
Drivers of new technology development in microbial fermentation are similar to those for cell-culture processes and include reducing costs, increasing efficiency/productivity, and enhancing quality, s…
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Setting Standards for Biotech Therapeutics in India
• Limited experience with biotech processes and products. Limited experience with biotech processes and products is a challenge faced by many government organizations in India and across the world. Ap…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
The years 2008-2012 were more about implementing QbD with the industry incorporating the various elements of QbD into its approaches of process and product development. This phase also included discus…
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A Q&A With Parrish Galliher About Adopting Single-Use Systems
It’s well underway and is moving into commercial plants—we know of five single use facilities around the world that are either licensed or are in the process of being licensed for commercial manufactu…
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Flexibility in Biopharmaceutical Manufacturing
The choice between stainless steel and single use is influenced not just by the economics of batch size and cost of goods but also by the speed by which processes can be configured and started up. Thi…