An increasing number of medications, including new treatments for cancer and autoimmune diseases, are grown inside genetically modified living cells. While many of these drugs, known as biologics, as well as cell and gene therapies, offer promising results, the process of designing and growing the necessary cells, isolating the useful proteins, and delivering them safely to a patient can be a challenge.
Northeastern’s Biopharmaceutical Analysis Training Laboratory, BATL, is expanding its ability to help people in the pharmaceutical and biotechnology industry navigate this process, with $4.3 million in funding from the Massachusetts Life Sciences Center. BATL will open a new facility on Northeastern’s Innovation Campus in Burlington, Massachusetts, to train students in drug creation, manufacturing, and regulatory steps.
“It’s really a holistic approach for the industry,” says Jared Auclair, who is the director of BATL and an associate teaching professor of biotechnology. “From the technical aspects, to the regulatory aspects, to the data management aspects and beyond.”
Currently, BATL offers trainings on Northeastern’s Innovation Campus, as well as around the world. Instructors work with individuals from academic institutions, pharmaceutical companies, and regulatory agencies to provide training in manufacturing practices and regulatory considerations, ensuring that quality medication can get to the patients who need it.
“The field moves very quickly,” Auclair says. “It’s ever-evolving from year to year. Even the regulatory processes evolve pretty quickly as technology advances and we learn new things.”
The new space will include a facility specifically designed to teach students how to comply with federally-mandated standards for manufacturing pharmaceuticals, known in the industry as Good Manufacturing Processes. Biologics tend to be more sensitive to temperature than conventional drugs and are easily contaminated by microbes. This facility will allow students to practice maintaining a sterile environment throughout the process.
The new space will also have a manufacturing suite where students can grow cells and produce test batches of different biologics or other advanced therapies to understand the process and where things can go wrong. Biologics have a much more complicated structure than, say, a molecule of ibuprofen or some other conventional drug. This makes it much harder to confirm that one batch of medicine is exactly the same as the previous batches. Having consistent, precise manufacturing processes ensures that biologics work as intended.
“We’re promoting science-based, risk-based evaluation of drugs, ensuring the quality of those medicines,” Auclair says. “We bring people on site from around the world for experiential training, and it emphasizes Massachusetts as the world-leading hub of biotech and pharmaceuticals.”