Search results for " process validation" in Articles / App Notes

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
With the most recent FDA (1) and Inter-national Conference on Har-monization (ICH) guidances (2-4) advocating a new paradigm of process validation based on process understanding and control of paramet…

Article The Lifecycle Change of Process Validation and Analytical Testing
BioPharm International spoke with Hal Baseman, COO and principal at ValSource LLC and co-leader of the Parenteral Drug Association Process Validation Interest Group; Paul Smith, EMEAI laboratory compl…

Article Assessing Manufacturing Process Robustness
In 2011, FDA’s revised process validation (PV) guidance (7) extended ICH’s concepts to the pharmaceutical product lifecycle, an approach that is now being applied to cleaning validation and other area…

Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation

Article Mapping a Route for Cell and Gene Therapy Process Development
Common validation hurdles One of the primary requirements for process validation is to demonstrate documented evidence that the scaled process can consistently produce the final product, meeting t…

Article Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages. Cynthia A. Challener  Upstream viral-vector processes can have sig…

Article Continued Process Verification for Biopharma Manufacturing
Guidance issued by FDA in 2011 (1) emphasized the importance of manufacturers undertaking CPV as an integral part of the process validation lifecycle. CPV will provide the manufacturer with assurance …

Article Achieving Process Balance with Perfusion Bioreactors
Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run. By Cynthia A. Challener  MG/Stock.Adobe.com …

Article Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes. By Susan Haigney natali_mis/Stock.Adobe.com Regulators have been en…

Article Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved. By Feliza Mirasol Selecting an appropriate separation technology fo…

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