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 ...

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 ...

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 ...

So, you have a great idea for a new fermentation-based product or ingredient, and a successful process in the lab. All that remains is to scale up to mass production. That’s just a matter of running ...