Biopharmaceutical Analysis: GC-MS

November 01, 2019

The following details some of the latest tools and systems available for biopharmaceutical laboratory operations.

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.

July 01, 2018

Process analytical technology tools have enabled manufacturers to monitor and control their production processes.

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.

August 01, 2016

A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.