New Thermo Fisher Deal Aims to Improve Biopharmaceutical Analysis

Thermo Fisher Scientific and the Biopharmaceutical Analysis Training Laboratory (BATL) at Northeastern University recently entered into an agreement to drive innovation across the biopharmaceutical analysis and characterization. 

By combining BATL’s technical training programs for regulators, industry personnel, and academics and Thermo Fisher’s liquid chromatography-mass spectrometry technology, the organizations aim to create analytical solutions and deliver training to meet industry needs, such as personalized medicine, monoclonal antibodies, and gene and cell therapies

"In the last few decades we've seen the development of novel biotherapies, such as gene therapies and personalized medicines, to treat a myriad of diseases, and this level of innovation within the biopharmaceutical industry continues to grow," Eric Grumbach, director of biopharma/pharma, chromatography and mass spectrometry, at Thermo Fisher Scientific, said in the announcement.  

"With new therapies, there comes a need for forward-looking analytical techniques and methods to deliver the sensitivity and accuracy required to ensure the safety and efficacy of drugs,” Grumbacj added.

When biosimilar developers attempt to re-characterize products that were developed years ago using current analytical tools, many details are revealed that pose a threat when developing a product within the required specifications.

Biopharma characterization helps to define features of a biologic in specific detail so that researchers can understand all aspects of development and manufacturing. The process can also alleviate the cost attached to clinical trials. 

Biopharmaceutical products are advanced and widely available to patients in different therapeutic areas, but because the product is so “sophisticated”, there are still byproducts. Experts do not completely understand which of these byproducts will give unwanted side effects and which will not, Hermann Wätzig, chair of the pharmaceutical analysis/quality control division of the German Pharmaceutical Society, said in a 2018 article. 

Thermo Fisher Scientific’s collaboration with BATL will provide biopharmaceutical organizations with vital analytical solutions needed to answer these important scientific questions, all while still meeting regulations and enhancing operations, the drug company said. 

Advances in these analytical solutions allows biosimilar manufacturers to identify any product differences between the biologic and the reference product that may affect the safety and efficacy of the biologic.

Thermo Scientific Orbitrap Exploris 240 mass spectrometer and Thermo Scientific Vanquish Duo UHPLC System  have the accuracy, precision, and reliability to analyze the molecules defining future medicines, a Thermo Fisher Scientific spokesperson said. 

The Orbitrap Exploris 240 mass spectrometer has proven to meet the requirements of late-stage biopharmaceutical developers for flexibility, improved accuracy, operational simplicity, and quick turnaround times. 

Additionally, this system typically works across a range of samples of various characteristics because of its ability to deliver consistent results regardless of complexity. 

BATL also selected the Vanquish Duo UHPLC System because of its ability to be operated in tandem mode. This decreases wait time for column equilibration and enhances biopharmaceutical analyses, Thermo Fisher Scientific noted. 

"Our progressive training programs focus on the science- and risk-based evaluation of therapeutics, allowing scientists to reduce the regulatory burden and deliver potentially lifesaving drugs to patients more quickly,” said Jared Auclair, associate dean of professional programs and graduate affairs and director of the Biopharmaceutical Analysis Training Laboratory.

“This collaboration with Thermo Fisher not only provides us with the analytical power we need from our instruments, but also allows us to drive the development of valuable biopharmaceutical characterization and monitoring workflows to address the ever- evolving analysis needs within the industry,” stated Auclair.