Northeastern University is the first institution in the Western Hemisphere to be selected as a “Center of Excellence” charged with educating regulators from 21 countries about the structure, function, and production of biotherapeutics—a class of drugs developed using living cells rather than from chemical synthesis.

Those countries make up the 21 member economies of the Asia-Pacific Economic Cooperation. In addition to being APEC’s only Center of Excellence in the Western Hemisphere, Northeastern is the only one devoted to biotherapeutics.

Based at the Biopharmaceutical Analysis Training Laboratory at Northeastern’s Innovation Campus in Burlington, Massachusetts, the center will provide to professional drug regulators and industry drug developers both academic and hands-on training to elucidate the nature of these protein-based medicines as well as the technical challenges involved in their manufacture and regulation. Unlike synthesized drugs, biotherapeutics cannot be reproduced exactly, making sophisticated analysis and characterization of their makeup and action essential to ensuring their safety and effectiveness.

“There is an international need to bring knowledge about protein-based medicines to a much higher level within regulatory agencies,” said David Luzzi, Northeastern’s vice provost for research innovation and development and vice president of the Innovation Campus. “By a unanimous vote, APEC, an important multinational organization, has now officially endorsed Northeastern as the first place in the world that is specifically chartered to carry out this mission, bringing rigor to the drug regulatory and approval process throughout the Asia-Pacific region.”

EXPERIENTIAL LEARNING

In September 2017, Northeastern’s Biopharmaceutical Analysis Training Laboratory began hosting regulators from APEC nations for four-day sessions comprising online, experiential, and case study learning experiences. Luzzi expects about 1,000 professional students to complete the program each year.

The curriculum, developed in partnership with a 47-member global technical advisory committee, will include hands-on training in protein and peptide analysis using methods such as state-of-the-art liquid chromatography and mass spectrometry; molecular comparison of different drug lots over the product lifecycle to ensure consistency in quality; and clinical assessments of so-called biosimilars—biotherapeutics that are similar, but not identical, to biologics that have already gained regulatory approval.

“For decades Northeastern has been a world-class leader in developing the methodologies to analyze complex molecular structures,” said Luzzi. “Bringing the APEC regulators to BATL will continue to put the university at the forefront of educating researchers and quality-control experts about these revolutionary agents.”

Northeastern formed the training laboratory in June 2014 in collaboration with Waters Corporation, one of the world’s leading specialty measurement companies. Waters has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, and food sciences for nearly 60 years. This partnership will enable Northeastern and Waters Corporation to deliver value to the worldwide effort to improve the development and regulation of biotherapeutics.

“In this strategic partnership, we will continue to work closely with Northeastern to ensure that cutting-edge technologies are available to enable full characterization of biotherapeutics,” said Richard Ladd, senior director of pharmaceutical business at Waters. “With other committed thought-leaders, stakeholders, and government and industry leaders, we are proud to support BATL in its endeavor to promote a global understanding of the key innovations and regulations that address the complex world of biotherapeutics analysis.”

Support from the pharmaceutical industry will cover the APEC regulators’ tuition,housing, and travel expenses while they are studying at Northeastern. Biogen, a pioneering biotechnology company based in Cambridge, Massachusetts, has joined the center as the lead funding partner.

A GLOBAL IMPACT ON HUMAN HEALTH

APEC is a 21-nation forum established in 1989 to promote free trade and sustainable economic growth throughout the Asia-Pacific region. Northeastern’s center is a member of the first class of APEC Centers of Excellence, which will eventually cover six priority areas of drug and medical-device regulation.

Northeastern’s center is unique not only in its concentration on biotherapeutics but also because of its experiential focus. “While other centers rely on lectures and case studies in the classroom, our center includes actual time working with the sophisticated equipment that industry uses to develop new biotherapeutics and prepare submissions to regulatory authorities,” said Luzzi, who led the center’s application and pilot-approval process with its executive director Jared Auclair, director of Northeastern’s Biotechnology Professional Science Masters and Training, and Jeffrey Agar, associate professor in the College of Science.

In so doing, Auclair said, “Northeastern’s center reflects the university’s commitment to hands-on, use-inspired research that solves worldwide challenges. This is an amazing opportunity for Northeastern to make a global impact on human health in the APEC economies and around the world,” he said. “The government regulators we educate will protect their citizens from harmful drugs and enhance the approval process for biotherapeutics that will have tremendous medical benefit. The designation is a testament to the university’s standing in the world as a leader not only in the analysis of complex molecules but also in global experiential education.”

Originally published in news@Northeastern on October 3, 2017.