Continuous manufacturing and a quality-by-design development approach are a natural fit. FDA, as well as other regulatory agencies around the world, have for many years been encouraging drug makers to ...

Companies are evolving from static reports to living models by strengthening their data backbone with advanced analytics and ...

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 ...

Continuous processing can get products to market about 12 months faster than batch processing, according to a 2022 paper by the FDA. Understandably, the drive to transition to continuous bioprocessing ...

Batch remains advantageous for development, variable demand, and bounded risk, benefiting from natural hold points, simpler investigations, and lower upfront capital, despite longer lead times and ...

The biopharmaceutical industry has seen substantial growth in recent years, generating novel biotherapeutics and biosimilars at an unprecedented rate. One of the biggest challenges in the industry is ...

Indian pharma could consider continuous flow processing technology which is a cost-effective alternative to batch processing. This is because consistency in manufacture is an ongoing challenge. Flow ...