Analytics

Aaron M. Robitaille is senior product marketing manager with Thermo Fisher Scientific.

Brandon J. Bills is product manager, Thermo Fisher Scientific.

Articles

Intelligent analytical tools detect impurities to help ensure the quality of small-molecule drug ingredients.

Stepping Up the Search for Unknown Impurities

Kieran O’Connor is Analytical Science and Technology senior chemist at SK biotek, Ireland, kieran.oconnor@sk.com. (formerly Bristol Myers Squibb)

John Wasylyk is senior principal scientist at Bristol-Myers Squibb, USA; john.wasylyk@bms.com

Bob Wethman is senior research scientist II at Bristol-Myers Squibb, USA

Ming Huang is senior research investigator I at Bristol-Myers Squibb, USA

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing. 

Spectroscopy Facilitates Lean Analysis

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Leveraging vast quantities of analytical data requires digitalization and platform integration. 

Paradigm Shift for Data Analysis and Interpretation

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

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.

E&L Risk Assessment for Biologic Drug Products

Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.

Impurity Testing

Webcasts

Join experts from SGS and Thermo Fisher Scientific to hear how to improve workflows for confident extractable and leachable studies. 
Live: North America: Tuesday, Oct. 31, 2017 | 11am EDT | 10am CDT / Europe: Tuesday, 7 Nov., 2017 | 9am GMT | 10am CET / On Demand available after airing until 7 Nov., 2018. 
Register free: http://www.pharmtech.com/pt_w/analytical 


Bio/Pharmaceutical Analysis, GC-MS