Biopharmaceutical Analysis

Grant Playter is the Assistant Editor for 

Articles

Waters XBridge Premier GTx BEH size exclusion chromatography (SEC) columns are designed to improve analysis while lowering the cost of gene therapies.

Waters Launches SEC Columns for Gene Therapy Applications

A new portfolio of chromatography and mass spectrometry consumables launched by Thermo Fisher Scientific is designed to meet higher performance requirements while remaining economical.

Thermo Fisher Scientific Introduces New Portfolio of Chromatography and Mass Spectrometry Consumables

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

The Latest in the Laboratory

Valerie Theobald is director, immunoanalytical services at Charles River Laboratories. 

Jenifer Vija is scientific director, bioanalysis, at Charles River Laboratories.

Jessica St. Charles is director, laboratory sciences at Charles River Laboratories.

Christina Satterwhite, PhD, is senior director, global laboratory sciences at Charles River Laboratories. 

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.

Emerging Therapies Test Existing Bioanalytical Methods

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

FDA Expands NDMA Investigation to All ARB Class Drugs

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.

Extraction System for Rapid Sample Preparation of GC/LC Samples

Yuanyuan Cui is Process Engineer III, Global Manufacturing Science and Technology at Sanofi.

Zheng Huang is Director, Global Manufacturing Science and Technology at Sanofi.

Jack Prior is Head, Global Manufacturing Science and Technology at Sanofi.

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

Using Direct Transition Analysis in Chromatography

Feliza Mirasol is the science editor for 

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

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

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


Phenomenex Opens New Manufacturing Facility

Aled Jones, PhD, is senior product manager at ProZyme.

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


Biopharmaceutical Analysis: Gas Chromatography