With the increasing international focus on biotherapeutics, there is rising demand for the pharmaceutical industry to be regulated on the global scale. As an advocate for regulatory convergence, the World Health Organization (WHO) has developed guidelines and recommendations for these biological products. However, each government harbors its own regulatory agencies, which have the latitude to formulate different requirements for their own countries.

One challenge faced by regulators and the industry in moving toward convergence is the lack of knowledge, especially hands-on training with the new technologies. Local, national, and international training efforts are needed to gain more expertise on the potential ways to analyze and characterize these molecules to ultimately increase the safety and efficacy of biotherapeutics.

The Center of Excellence for Biotherapeutics at the Northeastern University Biopharmaceutical Analysis Training Laboratory (BATL) will help build expertise and know-how by bringing together scientists and regulators from around the globe for experiential education, specifically hands-on training in these new technologies. The curriculum development involves an integrated effort between academia, the industry, and representatives from boards and health ministries.