Industry Leadership - Extractables and Leachables l VR Analytical


Raymond Colton, President
Raymond Colton is the President of VR Analytical, which specializes in extractables and leachables testing. He founded the company (formerly Validation Resources LLC) in 2001. He was early to recognize and understand the challenges associated with manufacturing materials interacting with drug formulations. He knew it would take dedicated resources and expert staff to develop the scientific methods necessary to mitigate the risks associated with the increasing use of polymeric materials in the manufacturing process. Colton likes to say that he has been doing this since before the term “single-use” was commonly associated with the manufacturing of biological drugs.

As president, he oversees financial operations and manages strategic growth opportunities for the company.

Colton earned his Bachelor of Science degree in Chemical Engineering from Clarkson University in New York and a Master of Science in Chemical Engineering from the University of Washington. He also obtained an MBA from New York University.

Colton is the author of numerous presentations, published papers, and a book chapter. He was also the lead author for the first two papers about extractables and leachables published by the Bio-System Pharm Alliance (BPSA) in Bio-Process International. He is a member of the Parenteral Drug Association, the Bio-Process Systems Alliance, and the Oregon Bioscience Association.


Trent Volz, PhD, Principal Scientist
Dr. Volz serves as a Principal Scientist for VR Analytical. In this role he leads a team of scientists performing cGMP-regulated analytical testing to detect and identify trace unknown organic and inorganic extractable and leachable contaminants in bio/pharmaceutical formulations. He specializes in advanced spectrometric interpretation (FTIR, high resolution MS, and UV-Vis) for identification and structural elucidation of small molecules. He also serves as the equipment operator of the UHPLC quadruple-time-of-flight mass spectrometer (QTof).

Prior to working with VR Analytical, Dr. Volz did a neuropharmacology post-doctoral fellowship with the Department of Pharmacology and Toxicology at the University of Utah, and served as a research assistant professor with joint appointments to the Department of Pharmacology and Toxicology and the Interdepartmental Program in Neuroscience.

Dr. Volz earned his Ph.D. in analytical chemistry from Washington State University and his Master’s and Bachelor’s degrees from the University of Alaska Fairbanks.