Search results for " validation"
Article
Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
Poster
Case Study: Improve Process Economy by Cycling of Prepacked Chromatography Columns
The use of disposable technologies in downstream processing has increased significantly over the last years, as they reduce the need for time-consuming cleaning and cleaning validation operations as…
Article
Improvements in Protein A Chromatography
In addition, it would likely lead to the development and validation of a Protein A resin storage procedure for use during plant shutdown. This effort is often justifiable only after mAb licensure and …
Article
Defining Risk Assessment of Aseptic Processes
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
By Susan J. Schniepp
Q: I work in …
Article
Real Time Continuous Microbiological Monitoring
Therefore, both CFU-based plate count monitoring and bio counts monitoring should run in parallel for microbial monitoring (at least through validation and implementation).
Any change in env…
Article
Mixing dynamics in a large volume single use mixer
Dissolution studies will be used in the future to understand the liquid-liquid and powder-liquid mixing times along with zone mapping and test validation.
Download the application note.
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
Article
Lessons Learned Accelerate Vaccine Development
In addition, disposable technologies offer the potential to eliminate equipment cleaning, process cleaning validation, and cross-contamination, plus facilitate changeovers between processes, according…
Article
Continuous Processing for the Production of Biopharmaceuticals
The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platf…
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Regulatory constraints
Regulatory restrictions may exclude some cell-detachment methods from consideration in particular applications or require extensive validation before authorization of use is…