Search results for " capture" in Articles / App Notes
Article
The Affordable Care Act's Impact on Innovation in Biopharma
With an increasing emphasis on post-market safety surveillance and real-world evidence, companies must have the appropriate measures put in place to capture this information.
• Clinical groups wil…
Article
Trends in Downstream Bioprocessing
At present, most industry decision-makers find current Protein A, particularly, in the US and EU (versus the rest of the world), to be an adequate, if expensive, solution for antibody capture. Alterna…
Article
FDA Seeks Metrics to Define Drug Quality
The next level captures higher average disposition cycle times or operator errors per batch. Documented quality events, overdue regulatory commitments, or an increase in rejected batches may signal th…
Article
QbD and PAT in Upstream and Downstream Processing
Not all of these are amenable for online applications, but together they capture various attributes of upstream processing.
BioPharm: Given the inherent variability in biologics manufacturing, how…
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
Quality by design for biotechnology products—part 1
The paper is intended to capture and reflect both the current and future state of QbD implementation. Therefore, new tools and terminology (e.g., expanded change protocol and the post-approval managem…