The business case for regulated AI turns on the cost of producing an outcome that the quality system can accept.
|Articles|June 27, 2023
People and Culture Drive Operational Excellence
Author(s)Societal CDMO
The overall success of an organization is driven by the team that makes it. Many seek to create a culture of continuous improvement, but the path to get there is not always clear. Empowering employees and involving them in key decisions is vital in achieving an environment of operational excellence and strong company culture.
Related to this article
In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for clinical trials, AI, and moving away from animal testing.
Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.
Structural modifications can improve peptide stability, solubility, and absorption to enable effective oral delivery.
The FDA approves VOCERYQ, the first DNA medicine, for RRP surgery reduction, raising plasmid, drug-device, and confirmatory trial manufacturing demands.
Continuous overall equipment effectiveness can be used to pinpoint hidden downtime and process bottlenecks in real time.
Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.
The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
Trending on Pharmaceutical Technology
1
FDA’s New Inspection Playbook Counts Remote Assessments and MRA Reports Toward Facility Evaluations
2
RRP Accelerated Approval: What VOCERYQ Means for Manufacturing Teams
3
Who Answers for Your Data? Building a Life Sciences Data Mesh
4
Late-Phase Impurities Need Reference Standards: AAPS PharmSci 360 2026
5