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November 01, 2019
The following details some of the latest tools and systems available for biopharmaceutical laboratory operations.
April 15, 2019
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
September 04, 2018
As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.
March 05, 2018
CEM reports that the EDGE extraction system for rapid sample preparation of gas chromatography/liquid chromatography samples from CEM can prepare samples for molecular analysis within 5 min.
January 01, 2018
The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).
October 01, 2017
Process analytical testing for biopharmaceuticals requires enhanced methods due to complex bioprocesses.
June 02, 2017
Phenomenex opened a new manufacturing and development facility in CA for the company’s gas chromatography columns.
June 01, 2017
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
February 01, 2017
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
August 17, 2016
The Chinese facility was cited for data integrity violations.