Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
|Videos|July 7, 2023
Exploring Holistic Data Integration Strategies with Kelly Doering
Kelly Doering, senior director at Aspen Technology, unpacks various strategies for holistic data integration into pharma operations.
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Kelly Doering, senior director at Aspen Technology, sat down with Grant Playter, associate editor, to unpack various strategies for holistic data integration into pharma operations.
Topics of discussion include how manufacturing parameters impact the value of different data sets, balancing data democratization with very large data volumes, the role of data in promoting global access to medicine, and more.
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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.
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.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
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