Finished Product Analysis

Apr 01, 2018
BioPharm International
Updated guidelines and new technologies aid visual inspection of parenteral products and packaging.
Jan 01, 2018
BioPharm International
Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.
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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
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.
Jun 01, 2017
BioPharm International
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
Feb 01, 2016
BioPharm International
Time and sensitivity are essential for analytical technologies in all phases of biopharma development.
Oct 01, 2015
BioPharm International
The authors present the results of a survey of biologics manufacturers to evaluate how these manufacturers transfer analytical methods.
Aug 01, 2015
BioPharm International
Industry experts spoke to BioPharm International about the key considerations in the development of a drug-delivery device for a biologic drug, the importance of human factors engineering, the advantages of prefilled syringes, and the challenges in the manufacture of these devices.
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