Validating The Simoa Technology

Overview


Validating-The-Simoa-Technology.jpg

Frontage is the first and only laboratory to validate Quanterix’ Simoa HD1 Analyzer for performing immunoassays.

Most of the advanced instruments used in bioanalysis—such as Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), and Liquid Chromatography-Mass Spectrometry (LC-MS) for example—are automated. Thus, they are controlled by complex computer systems, and the information they generate is stored electronically. If these systems are to be used in regulated research studies in the US, EU, and Japan, the instruments themselves must be qualified and their supporting software and processes must be validated as meeting regulatory requirements.

This content is provided by Frontage Laboratories, and any views and opinions expressed do not necessarily reflect those of Outsourcing-Pharma.com

Download Now


Related Resources

Outsourcing Analytical Testing for Biologics - A CRO's Perspective

Outsourcing Analytical Testing for Biologics - A CRO's Perspective

Content provided by Frontage Laboratories

White Paper

Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed, proteins, given their chemistry, are the “most structurally complex and functionally sophisticated...

How to Avoid Surprises in Small-Molecule Drug Development Programs

How to Avoid Surprises in Small-Molecule Drug Development Programs

Content provided by Frontage Laboratories

White Paper

Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent of Phase III studies failed due to safety (compared to 55 percent for efficacy), down from 21...

Supplier Info Centre

Frontage-Laboratories.png

For more product information visit Frontage Laboratories.