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.
|Articles|December 9, 2022
The Cornerstone of Virtual/Outsourced Drug Development: CMC Project Management
Author(s)Syner G
In the pharmaceutical industry as a whole, the reliance on a virtual drug development model that involves global outsourcing of CMC activities has greatly increased.
Related to this article
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.
Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
Trending on Pharmaceutical Technology
1
FDA’s New Inspection Playbook Counts Remote Assessments and MRA Reports Toward Facility Evaluations
2
Late-Phase Impurities Need Reference Standards: AAPS PharmSci 360 2026
3
USP 1074 Revises Excipient Safety: AAPS PharmSci 360 2026
4
1074 Revision Needs Formulator Feedback: AAPS PharmSci 360 2026
5