Analytical Methods

Dec 05, 2017
By BioPharm International Editors
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
Dec 01, 2017
BioPharm International
A roundtable Q&A with biopharma executives elucidates the challenges posed by single-use bioreactor bags in contributing to extractables and leachables in the biomanufacturing process.
Dec 01, 2017
BioPharm International
A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.
Oct 01, 2017
BioPharm International
A UHPLC SEC approach for protein aggregate analysis of mAbs is presented.
Oct 01, 2017
BioPharm International
Process analytical testing for biopharmaceuticals requires enhanced methods due to complex bioprocesses.
Oct 01, 2017
BioPharm International
Detecting viral contaminants in biologic-based medicines—and identifying their source—requires a holistic testing approach.
Aug 01, 2017
BioPharm International
Industry experts weigh in on best practices, challenges, and mutual recognition of cleaning validation standards.
Jul 05, 2017
By BioPharm International Editors
A new probe developed by researchers at the University of Melbourne, Australia, would allow NMR to be used without the use of microwaves, and with smaller machines.
Jul 01, 2017
BioPharm International
While the measurement of the toxicity of leachables is not always a required parameter, the information collected during these studies could inform future bioprocessing runs.
Jun 01, 2017
BioPharm International
How statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.
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