Biopharmaceutical Analysis: Gas Chromatography

The Latest in the Laboratory

November 01, 2019

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

Emerging Therapies Test Existing Bioanalytical Methods

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.

FDA Expands NDMA Investigation to All ARB Class Drugs

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.

Extraction System for Rapid Sample Preparation of GC/LC Samples

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.

Using Direct Transition Analysis in Chromatography

January 01, 2018

The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).

The Challenges of PAT in the Scale-Up of Biologics Production

October 01, 2017

Process analytical testing for biopharmaceuticals requires enhanced methods due to complex bioprocesses.

Phenomenex Opens New Manufacturing Facility

June 02, 2017

Phenomenex opened a new manufacturing and development facility in CA for the company’s gas chromatography columns.

N-Glycan Analysis of Biotherapeutic Proteins

June 01, 2017

This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.

Evaluating E&L Studies for Single-Use Systems

February 01, 2017

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.

Zhejiang Medicine Receives FDA Warning Letter

August 17, 2016

The Chinese facility was cited for data integrity violations.