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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
March 02, 2020
Ensuring the quality of data in process monitoring and control systems starts in process development phases.
November 01, 2019
Accelerated timelines and small batch volumes of cell and gene therapies pose unique challenges for product-release testing.
March 01, 2019
Both empty and filled syringes must pass a range of tests to meet quality standards for biopharmaceutical drugs.
October 01, 2018
Analytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.
August 01, 2018
More complex biologic samples must be evaluated to ever higher levels of specificity and sensitivity.
April 01, 2018
RGtimeline/Shutterstock.comParenteral product quality is improving.
January 01, 2018
Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.
December 05, 2017
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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
October 01, 2017
Process analytical testing for biopharmaceuticals requires enhanced methods due to complex bioprocesses.
A UHPLC SEC approach for protein aggregate analysis of mAbs is presented.