Analytical Methods

Feb 01, 2018
BioPharm International
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the shortcoming with the contemporary approaches.
Feb 01, 2018
BioPharm International
The critical quality attributes of biotherapeutics must be monitored to ensure product safety and efficacy.
Jan 16, 2018
By BioPharm International Editors
Automated Control Concepts has launched Lab Owl bioreactor control system for labs using cell culture and fermentation applications.
Jan 11, 2018
By BioPharm International Editors
The 2018 Short Course program at Pittcon, taking place Feb. 24–Mar. 1, will feature 23 new short courses geared towards laboratory professionals.
Jan 01, 2018
BioPharm International
The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).
Jan 01, 2018
BioPharm International
Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.
Dec 12, 2017
By BioPharm International Editors
SGS has introduced a Sanger sequencing service at its Glasgow, United Kingdom, laboratory to support genetic stability testing and perform identity testing on cell banks, plasmids, and viral seeds/vectors.
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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.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.
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