The US FDA’s Process Analytical Technology (PAT) initiative provides a structure for “Quality by Design” (QbD) deployment. As part this initiative, knowledge of industrial processes is gained using ...
The utilization of online process analytical technology (PAT) has become a high-profile endeavor in the biotechnology industry in recent years. Since the early 1980s, many fermentation scientists have ...
Processes yielding >500 mg plasmid DNA/L have previously been reported by Merck, Boehringer Ingelheim, and Nature Technology (NTC). Common features among these high-yield processes include the use of ...
In the realm of biomanufacturing, space-time yield (STY) is increasingly recognized as an essential metric for evaluating upstream process efficiency. STY facilitates the direct comparison of various ...
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