It’s in Our DNA

To Mary Lynne Bercik ’90, design was always like standard project management: You needed to know how to put all the pieces together.

As executive director of global procurement at Merck Pharmaceuticals, Bercik, who graduated from Philadelphia University’s fashion design program, has parlayed that concept into a successful career in the pharmaceutical industry.

Her design background also played a significant role in the founding of the Jefferson Institute for Bioprocessing (JIB), the first—and only—specialized education and training institute for biopharmaceutical processing in North America that combines commercial single-use processing equipment with the internationally recognized National Institute for Bioprocessing Research and Training (NIBRT) curriculum. JIB opened its doors last May at Spring House Innovation Park in Lower Gwynedd, Pa.

The focus of JIB is to provide training to industry professionals through workshops and certificates and hands-on education of new bioprocessing engineers at the undergraduate and graduate levels.

With new biologic therapies turning acute and debilitating illnesses like rheumatoid arthritis, diabetes and cancer into manageable chronic diseases—and sometimes cures—Bercik was acutely aware of how biologics were rapidly gaining momentum throughout the world. These therapies represent the future of medicine and of patient care. The challenge today, however, is the complex manufacturing process and lengthier regulatory approval for biologics compared to traditional small-molecule drugs. Producing biologics, with only a handful of centers worldwide dedicated to training people on how to manufacture these potentially life-saving compounds, also presented an industry-wide dilemma.

Biopharmaceuticals and biologicals are manufactured in a living system such as a microorganism, plant or animal cell—often using recombinant DNA technology. More than 40 percent of the therapeutics in research and development are biopharmaceuticals.

A Philadelphia native, Bercik says the idea for opening such a facility in the U.S. came to her while attending an annual conference in New York City hosted by the Drug, Chemical & Associated Technologies Association (DCAT). It was there that she met Dominic Carolan, CEO of NIBRT, a global center of excellence for training and research in biopharmaceutical manufacturing located in Dublin, Ireland.

“I knew they were the gold standard in the world,” Bercik recalls. “Twenty-two percent of people who come to them for bioprocessing training in Ireland, including the companies that I used to work for, are from the rest of the world. I thought, what about coming to the U.S.?”

She took her idea to Dr. Ron Kander, founding dean of the Kanbar College of Design, Engineering & Commerce at Jefferson. With Philadelphia University and Thomas Jefferson University having recently merged, Bercik thought the stars were aligned for the creation of a bioprocessing facility in the Philadelphia region. Who better to approach with this idea than a university with strong legacy programs in science and health on one side—design, engineering and business on the other—and a commitment to train today’s students for the jobs of tomorrow.

An exploratory committee from Jefferson, led by Kathy Gallagher, executive vice president and chief operating officer, and Dr. Kander, was formed, and a trip to visit the NIBRT facility in Dublin soon followed.

“They were very excited to set up a joint partnership with us,” Carolan recalls. “They saw that NIBRT had been well established for a number of years and that we had the experience associated with getting a curriculum together. They wanted a fast start in Philadelphia so it was an obvious partnership. We were delighted to do it with them.”

A few months later, in February 2017, Jefferson formally approved the creation of the Jefferson Institute for Bioprocessing—affectionately known as “JIB.” The summer of 2017 was spent on planning and site selection, and by February 2018, less than two years after Bercik’s idea took flight, Jefferson signed the formal agreement with NIBRT and construction soon began.

Along the way, Jefferson joined NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals, a federally funded consortium of universities and industries based at the University of Delaware. Jefferson established key partnerships with Johnson & Johnson (Janssen), GE Healthcare, Merck, GlaxoSmithKline, Bristol-Myers Squibb, Wuxi AppTec and Shire, along with Montgomery and Bucks County Community Colleges.

JIB was formally unveiled with a ribbon-cutting ceremony on May 31, 2019. Less than three years had passed since Bercik first brought the idea to Dr. Kander.

“I could not have imagined all of this back when Mary Lynne and I were standing on the corner of 10th and Chestnut streets in Center City, Philadelphia playing with possible names for this project and dreaming up the JIB acronym,” Dr. Kander recalls. “What an amazing team effort, and it would not have been possible without the coming together of Philadelphia University and Thomas Jefferson University to form the new Jefferson.”

In many ways, JIB is the embodiment of the critical components of the merger, from the transdisciplinary education curriculum and programs, to market distinction, to growth and economics.

For Dr. Kander, JIB addresses the “three E’s”—economics, enrollment and esteem—of Jefferson. As an academic business unit, JIB will generate revenue; it’s providing industry training for jobs better than most universities, meaning enrollment will grow; and the relationship with NIBRT increases Jefferson’s international esteem.

“The Jefferson Institute for Bioprocessing will create a much greater intersection between industry, academics and health care,” says Dr. Stephen K. Klasko, president of Thomas Jefferson University and CEO of Jefferson Health, adding that the partnership with NIBRT perfectly captures the philosophy of what defines a Jefferson education—making sure students are prepared to lead in tomorrow’s world. “Jefferson is built on anticipating the emerging professions that will be commonplace 10 years from now and educating students in those disciplines today. The creation of JIB also puts our students at the forefront of where medicine is going.”

JIB’s state-of-the-art, 25,000-square-foot facility offers both the knowledge and training required to meet the continuingly evolving demand for the bioprocessing expertise companies need to stay competitive in the industry.

“This is the kind of facility you see in a manufacturing setting,” says Dr. Parviz Shamlou, JIB’s executive director. “To see this in an academic setting is what is surprising all of the colleagues that I’ve talked to.”

JIB’s curriculum includes a comprehensive range of education, training and workforce development offerings, including continuing education certificates, industry workshops and certified training courses. Jefferson also offers students MS degrees in biopharmaceutical process engineering and will add more degree options in the future.

“Pharmaceutical industry colleagues love it because they can now connect the formal degree programs, formal traditional education, to what industry needs,” Dr. Shamlou notes. “They can see how they can send their people to JIB for the training that they need. This is what we mean by filling the gap in bioprocessing.”

Through its partnership with NIBRT in Dublin, Jefferson has widened its ever-expanding international footprint and bolstered its reputation, having already opened global education, health and innovation centers in Israel, Japan, Italy and India. In addition to these centers, Jefferson leverages other global academic partnerships to benefit our students with such institutions as St. George’s University of London, Catholic University of the Sacred Heart in Rome, Kitasato University in Japan, Universidade do Minho in Portugal and many others.

NIBRT, internationally recognized for its excellence in bioprocessing research and training, serves about 4,000 industry professionals worldwide at its headquarters in Dublin, including many from the U.S. JIB will leverage the renowned NIBRT curriculum to provide a premier U.S.-based option with a significant potential market that includes 900-plus pharmaceutical-related companies in the Northeast. The Institute will also utilize the latest single-use engineering technology pioneered by General Electric.

“The Jefferson Institute for Bioprocessing promises to be the training ground for the pharma industry here in the U.S.,” says Dr. Mark L. Tykocinski, Jefferson’s provost and executive vice president for academic affairs. “Its establishment will give us an enormous advantage as a university and will bring considerable know-how and expertise to the region that other universities will be able to avail themselves of."

State Rep. Liz Hanbidge, D-61st, who attended the May 31 ribbon cutting for JIB, is excited about the impact the Institute will have on the local economy. “I can’t wait to see the success, innovation, research and job creation that JIB will bring to Montgomery County and beyond,” she says.

Dr. Shamlou explains that the Institute is designed to simulate a certified Good Manufacturing Practice (GMP) plant where biologics are made. The final step JIB cannot do is produce finished products. He notes how manufacturing a therapeutic such as a monoclonal antibody is a detailed process that takes weeks to complete.

“Working on a medicine that you know will help a patient and to be able to see a drug out there that you know you had something to do with is what keeps the excitement alive,” Dr. Shamlou says.

As Dr. Klasko points out, JIB is the latest example of what makes Jefferson, Jefferson.

“You have access to this incredibly comprehensive and creative University that’s willing to take a no-limits approach, even beyond what you see in that bioprocessing technology,” he notes. “Anything that you want to work with, whether it’s engineering or business or medicine or design, we’re committed to redefining what is humanly possible.”

Now that JIB is up and running, Jefferson COO Gallagher sees no reason to stop with just one facility. “I want 20 Jefferson Institutes for Bioprocessing across all fields, across all industries,” she says. “I want it to be in this area, I want it to be national, I want it to be international. I want our students to work in real-life settings that set them up to be really, really successful in the future.”

To think, it all began with the simple idea of putting the right pieces, and people, together. “That’s what’s remarkable about Jefferson and the leadership here,” Bercik says. “They see new ideas and they are always eager to let them set sail. So it makes perfect sense to name this center JIB, which in sailing allows a boat to catch more wind and move faster. Innovations move quickly at Jefferson. It’s just a part of who they are.”