Thermo Fisher Scientific and BioAnalytix collaborate on biopharmaceutical analysis workflows

Scientists at Thermo Fisher Scientific and BioAnalytix are combining their expertise to develop advanced analytical profiling platforms and applications to characterise biologic and biosimilar drugs.

Biologic drugs, such as therapeutic monoclonal antibodies, are extremely large and complex biomolecules. They represent one of the most significant areas in the pharmaceutical industry; but minor differences in biologic structure from drug to drug, or from manufacturing lot to manufacturing lot, can profoundly affect these drugs’ safety and efficacy profiles. Sophisticated analytic workflows are therefore required to characterise the molecules accurately and ensure reproducible consistency during their development, scale-up and manufacturing processes.

Thermo Fisher and BioAnalytix are collaborating to develop advanced analytical profiling standards to support, enable and accelerate biologic and biosimilar drug development. BioAnalytix’s team of biologic drug experts will use Thermo Fisher Scientific’s Orbitrap-based mass spectrometers, along with the company’s sample preparation, separation/enrichment, standards, reagents and software, to develop advanced applications.

“This is an exciting real-world opportunity to showcase the ability of our technologies to provide unique, critical insights into protein structures,” said Ken Miller, vice president, marketing, for Thermo Fisher Scientific’s life sciences mass spectrometry business.

“In partnership with top pharmaceutical companies and technology leaders like Thermo Fisher Scientific, it is our goal to establish and leverage leading analytical profiling standards in advancing the development, manufacture and regulatory approval of biologic and biosimilar drugs worldwide,” said Kirt Poss, president and CEO of BioAnalytix.