Search results for " specification"
Article
Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
Article
Automated Concentration and Diafiltration of Multiple siRNA Samples
…spectrometry (LC/MS) are used to analyze the quality of the starting feed material and to assign lot specifications for further downstream purification.
The ssRNA product is purified using…