Marking the beginning of a collaboration to develop advanced analytical methods to characterize biologic and biosimilar drugs are: (l. to r.) Kirt Poss, president of BioAnalytix; Shiaw-Lin (Billy) Wu, head of analytical sciences at BioAnalytix; and Mary Lopez of Thermo Fisher Scientific.Photo courtesy of Thermo Fisher ScientificBiologic drugs, such as therapeutic monoclonal antibodies, are extremely large and complex biomolecules, and represent one of the most significant areas in the pharmaceutical industry today. Minor differences in biologic structure from drug to drug, or from manufacturing lot to manufacturing lot, however, can profoundly affect these drugs’ safety and efficacy profiles. 

Sophisticated analytic workflows are therefore required to characterize the molecules accurately and ensure reproducible consistency during their development, scale-up and manufacturing processes. As respective leaders in analytic system performance and precise biologic analysis, Thermo Fisher and BioAnalytix are collaborating to develop advanced analytical profiling standards to support, enable and accelerate biologic and biosimilar drug development. 

Under the collaboration, 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. 

“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. 

“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. “We have a long history of successful collaboration with BioAnalytix scientists, and we look forward to continuing this productive relationship.”