The FDA approves VOCERYQ, the first DNA medicine, for RRP surgery reduction, raising plasmid, drug-device, and confirmatory trial manufacturing demands.
|Podcasts|June 29, 2022
The Right Partner to Advance Your Molecule From Gene to Commercialization – The Right Step to Advance Your Molecule
Author(s)Samsung Biologics
Samsung Biologics is responding to industry challenges with various development projects and services that improve overall timelines and efficiencies when manufacturing new medicines.
- Advantages of outsourcing development projects to CDMOs,
- Preventing challenges and starting the development process quickly, and
- Choosing a CMO partner with a highly optimized cell line platform.
Related to this article
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.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
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
AAPS PharmSci 360 2026: Spray Drying and ASD
4
USP 1074 Revises Excipient Safety: AAPS PharmSci 360 2026
5