An increasing number of medications, including new treatments for autoimmune diseases and cancer, are being grown inside genetically modified living cells. Many of these cells are known as biologics, and gene and cell therapy offer promising results. It is a great challenge to design and grow the necessary cells, isolate the useful protein, and deliver them safely to a patient.
Northeastern University’s Biopharmaceutical Analysis Training Laboratory, BATL, received a $4.3 million funding from the Massachusetts Life Sciences Centre and is helping people in the pharmaceutical and biotechnology industry navigate the process to create biologics in the needed environment. BATL will open a new facility to train students in drug creation, manufacturing, and regulatory steps on Northeastern University’s Innovation Campus in Burlington, Massachusetts.
“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 is offering training on Northeastern University’s Innovation Campus, as well as around the world. They work with individuals from pharmaceutical companies, academic institutions, and regulatory agencies to provide training in regulatory considerations and manufacturing practices ensuring that quality medication can get to the patients.
“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.”
This new space will include a facility specifically designed to teach students how to comply with federally-mandated standards for manufacturing pharmaceuticals. The facility will allow students to practice maintaining a sterile environment since biologics tend to be more sensitive to temperature than conventional drugs they are easily contaminated by microbes.
“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.”