Search results for " documentation" in Articles / App Notes
Article
Biopharma Seeks Balance
Biopharma Seeks Balance
Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.
By Rita C. Peters
…
Article
Making the Move to Continuous Chromatography
Making the Move to Continuous Chromatography
Early adopters are benefiting from lower costs and increased productivity.
By Cynthia A. Challener
Tashatuvango/Shu…
Article
FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
Ibreakstock/Shutterstock.co…
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
Reliability Rooms and the Move to Proactive Supply Chain Management
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict tren…
Article
Asked and Answered: Your Questions on Ion-Exchange Chromatography
On May 17, 2017, Marianne Carlsson presented the webinar, “Tips for Successful Ion Exchange Chromatography.” After the webinar, Marianne and a panel of R&D scientists participated in a live questio…
Article
Protein Purification Questions and Answers from ÄKTA Club Web Chat
Do you have recurring discussions in your lab that you need input on? Or do you need support to get on with your protein purification? Around 40 protein purifiers joined our latest ÄKTA club we…
Article
Ensuring Sterility in Small-Scale Production
In other words, the environment must be maintained and monitored with the recommendations specified in the documentation governing aseptic processing.
Properly maintaining an environment suitable …
Article
Automating Processes in Upstream Processing
By Susan Haigney
BioPharm International spoke with Trevor Marshall, director of enterprise systems integration at Zenith Technologies, about automating processes in upstream processing.
BioP…
Article
Reporting Quality Metrics to FDA
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
By Siegfried Schmitt
Q: We are a contract manufacturing organization (CMO), sp…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…