Tuesday, March 7, 2023 Daily Archives

Responding to a Changing Drug Product Global Supply Chain

Of the many lessons learned during the pandemic, one overriding realization was that utilization of the primary, single-location manufacturing site, although the simplest and potentially most cost-effective strategy, can have significant consequences to the availability of critical life-saving biologics and vaccines. This scenario not only applies to drug product but also to drug substance and the wide range of raw materials used throughout the manufacturing supply chain. Thus, the need for ongoing production from multiple drug substance (DS) and drug…

Cell and gene therapy sector needs purpose-built PAT

Process analytical technology (PAT) can help cell and gene therapy developers better understand and control product manufacture. But, to date, use has been limited according to researchers, who say the sector needs more purpose-built monitoring technologies. The conclusion comes from a study looking at how machine learning and metabolic modelling can be used to use process analytical technology in cell and gene therapy manufacturing. According to the authors “Process analytical technology (PAT) has demonstrated huge potential to enable the development…