Search results for " report"
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Setting Up Bioprocessing Systems for Digital Transformation
Unplausible results in downstream reports can easily be validated and verified using digital representatives with no further experimental effort. Such models can further be used for analyzing root cau…
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Effectively Managing Data in Process Development
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Traditional methods for capturing, storing, querying, and managing process development data are time-consuming, prone to error, and can hinder collaboration. Gain a deepe…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
Two examples are the International Site for Pharmaceutical Engineers and the Parenteral Drug Association, which have a lot of different guidelines or technical reports that are developed by groups of …
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Strategizing for Rapid Changeovers in Biologics Manufacturing
“Release handling is much easier when batch reporting, the data historian, and data analytics are maintained in a central place,” she says. “Process data can be accessed while a process is running wit…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
The report highlights operational savings from using concentrated stock solutions along with a buffer stock blending system. Savings vary based on the size of the facility and the capital cost require…
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Eliminating Residual Impurities Starts with a Strategic Plan
“Although full CMC [chemistry, manufacturing, and controls] information is not required until the market application dossier is submitted, a useful strategy is to prepare a comprehensive report that d…
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Gene Therapies Push Viral Vector Production
Some of the downsides include a limited payload, difficulty achieving high titers and functional titers, and difficulty in pseudotyping, Carstens reports.
The promise of AAV
Of the different v…
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Driving Improved Access to Biosimilars
According to reports on May 13 and May 21 in the Regulatory Affairs Professional Society Journal, the draft updates 2015 guidance on quality that FDA had withdrawn after receiving critical comments fr…
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2019 HTPD Conference is Approaching. What Happened Last Time?
The extended report, available as download, captures 15 of the presentations. Here’s a summary.
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2019 HTPD Conference Abstract Submissions Are Coming Up: What Happened Last Time?
The extended report, available as download, captures 15 of the presentations. Here’s a summary.