In the pharmaceutical sector, continuous manufacturing (CM) has emerged as a transformative technology with the potential to revolutionize the industry. As drugmakers seek to enhance efficiency, ...

The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with its good manufacturing practice (GMP) regulations under 21 CFR 211.110 governing batch ...

Continuous manufacturing makes monoclonal antibody production faster, cheaper, and greener, say researchers, who predict that industry adoption of the approach will accelerate in response to ...

The pharmaceutical industry has been slow to adopt a business practice that is faster, safer, and more efficient than its current way of operating; that the FDA has been encouraging the industry to ...

Fragmented plant data across silos drives late investigations and corrective action; connected architectures unify PAT, sensors, batch, quality, and maintenance signals to enable earlier risk ...

Continued process verification (CPV) is the third stage of the product lifecycle of any medicine either within the small or large molecule arena. The CPV is the subsequent step to process design ...

BioPlan survey data suggest that perfusion bioreactors remain confined to laboratory-scale processes but have matured enough ...

Scaling-up production of lentiviral vectors (LV)-based therapies is a persistent challenge for biomanufacturers, and one that threatens their development unless commercial-scale production ...

DIANT is a startup co-founded by Antonio Costa, Ph.D. and Diane Burgess, Ph.D. In 2020, DIANT licensed their core manufacturing technology from UConn and was granted a patent on the technology earlier ...

As noted in the first installment of this series investigating spending trends on automation technology across the discrete, batch, and continuous process industry verticals, this second installment ...

Andreas Eschbach is the founder and CEO of eschbach, a software company that helps production teams work smarter and enhance collaboration. Within the process industry, the chemical and pharmaceutical ...