WHAT BATL OFFERS
Located at the Northeastern University Innovation Campus in Burlington, Mass., BATL’s offerings comprise the latest analytical systems, including training in state-of-the-art liquid chromatography/ mass spectrometry analysis and relevant data management, focusing upon advanced characterization of a biotherapeutic’s structure, especially glycosylation. Experience on instrumentation such as ACQUITY UPLC H-Class and the XEVO G2 systems allow for an immediate transfer of knowledge into action for the student.
Experienced instructors from Northeastern University, partner universities, and industry are specifically chosen for each course topic to provide in-depth knowledge applicable to the lab environment. Courses offered at the BATL are designed to combine fundamental and applied knowledge in protein and peptide analysis and provide regulatory perspectives. All courses can be customized, and some topics can be given at off-site locations.
INTACT PROTEIN ANALYSIS
HANDS-ON LC/MS GLYCOPROTEIN AND GLYCAN ANALYSIS
PHARMACEUTICAL QUALITY TRAINING PROGRAM
Microcredentialing and more coming soon
WORKING TOGETHER TOWARD REGULATORY CONVERGENCE OF BIOTHERAPEUTICS
Dramatic scientific advances during the past 20 years in the field of biopharmaceuticals have had
a profound impact on the therapies available to physicians and their patients. Today, biologically active therapeutics allow doctors to manage chronic illnesses and diseases that, years ago, carried a death sentence. Yet despite the improvement in therapies yielded by the advent of biotechnology, regulatory issues in many countries still need to be addressed.
Because biotherapeutics, and thus biosimilars, cannot be exactly reproduced due to their manufacturing process, they present technical issues that—if not properly regulated—could result in adverse outcomes for patients. Although the WHO advocates for regulatory convergence and has developed guidelines and recommendations for these biological products, government regulatory agencies have the latitude to formulate the specific requirements for their countries. As these regulations for biotherapeutic products are being developed and implemented differently by different countries, there are regulatory gaps and disparities in capacities of responsible regulatory authorities.
Availability of regulatory expertise and resources, especially in evaluating complex biotechnology product submissions, is an issue for many countries. Increased regulatory cooperation and networking are essential prerequisites for a coordinated and efficient response to these realities. It is crucial that a roadmap toward greater convergence and harmonization is created to develop the regulatory guidance and requirements the field needs.
The establishment of consistent means of training and communication between industry and regulatory authorities has become a priority. For these reasons, the Center for Excellence in Biotherapeutics has been established in collaboration with APEC, specifically its Regulatory Harmonization Steering Committee (RHSC).