July 27, 2023

PROTECS design-builds first of its kind biotech facility in Innovation Park at Penn State

By Cara Aungst

In 2022, BioMagnetic Solutions bucked the status quo with an announcement that, instead of surrounding itself with other biotech companies in Cellicon Valley in Philadelphia, San Francisco, New York or Boston, it was instead surrounding itself with key resources that would help propel commercialization: Penn State’s world-leading expertise in supply chain management, materials, and analytical sciences. Today, they are poised to open a $10M facility that is the first of its kind in the United States and will create a magnetic force to bring other biotech companies to Happy Valley.

“The facility will be an asset that is unique to the entire country,” BioMagnetic Solutions’ CBO and co-founder Ted Liberti said. “It will turn on the spigot to create the tools, reagents and cell selection systems that help the therapeutic cell and gene therapy companies we serve to manufacture future remedies.”

How the facility will foster medical breakthroughs

“We’ve been known for our wonderful magnetic liquids for decades, right up to our present-day immunomagnetic FerroSelect system that depends on our magical Ferrofluids,” Liberti explained. “When selecting cells, one needs magnetics and monoclonal antibodies (mAbs). The antibodies identify the cells of interest and our Ferrofluids find the antibodies on the cells of interest for a one-two combination that makes it possible to remove selected cells magnetically. It’s a coffee and cream interaction — one needs both to succeed.”

Liberti said as BMS looked at contracting for GMP mAbs, they found that both pricing and timing were major factors in creating reliable mAbs.

Penn State is graduating a lot of students to feed into the field of bioprocessing and biopharma — biomedical, materials science, bioengineering, biologics and chemical engineering. It’s a microcosm of research, industry, and students all working in biotech and pharma.

“With the decision to manufacture our own GMP mAbs in-house along with our GMP Ferrofluids, our superpower, we gained several great advantages: better economics, timing and the ability to control our own destiny by manufacturing the antibodies we need to grow our clinical magnetic cell selection portfolio, but on our own timeline.”

Liberti said that the flexibility to manufacture multiple smaller antibody lots gives the company the flexibility to offer more product and services to their cell & gene therapy customers, while allowing for the future ability to manufacture smaller lots of GMP, injectable-grade, clinical antibodies for clinical trials by the world’s elite cancer centers.

“Clinical centers like MD Anderson,  Memorial Sloan Kettering, and others often face challenges getting hold of small-lot clinical grade cGMP antibodies and our new cGMP facility can help fulfill that important clinical demand,” Liberti said.

Building innovation with PROTECS

To create a facility that could perform at such a high level of performance, BioMagnetic Solutions turned to PROTECS, a full-service design/build, construction management company focused on serving the hi-tech regulated market sectors. Headquartered in Plymouth Meeting, PA, PROTECS is led by president and CEO Christopher DiPaolo, who founded the company as an answer to a problem he saw in the marketplace.

“I learned so much through fixing others’ mistakes that I was able to add more value to my role,” he said in an interview with Swagger magazine.

“I found it difficult to complete projects when employed at other companies because I couldn’t get the right person for the job, just the one that was available,” he said in the interview. “Through PROTECS leveraged design/build delivery methodology, we collaboratively partner with the best-in-class architectural and engineering professionals and provide our clients with 150-200 years of experience around the table at the formative stages of a project.”

There is a lot of dialogue and interface between academic teams and industry. Happy Valley can be a strong player and center of excellence for the growing biotech and bioprocessing industry. We can be an industry leading force.

Through PROTECS’ patented Target Costing® delivery methodology, the company acts as a single point of contact and accountability for master planning, site selection, design, construction, commissioning and validation. As part of this delivery approach, PROTECS takes on the risk to guarantee performance, conformance, compliance and cost to ensure all its clients’ strategic objectives and goals are met.

DiPaolo’s team met with BioMagnetics to create a vision for the new 12,500-square-foot facility that includes a validated cleanroom, laboratory and office operations. “The cleanroom areas have unidirectional personnel flows with pressurized cascading airlocks to ensure protection against cross contamination from room to room,” DiPaolo said. “There are support utility systems for purified water, steam, chilled water, air handler, emergency power, process vacuum, and compressed air.”

Because DiPaolo’s team is able to design, pre-purchase long lead equipment and build to the exact needs and cost structure of BMS through its Leveraged Design-Build™ project delivery methodology, it ensured that the project would meet the performance and conformance requirements, be delivered on-time and within the cost objectives. “The key is early involvement and alignment with C-suite leadership, investors and key scientists, to bring the vision to reality.”

“We are a relationship-based company,” DiPaolo said. “We do jobs as small as $100,000 and as big as $130 million because we believe that the $100,000 clients can become the $130 million clients. That’s what drives us. Anyone can build for companies with boundless funding, but when you have to build a high functioning facility with a limited budget, that’s a real skill. We’re enabling a lot of people to reach their goals and bring essential products to market.”

What does this mean for Happy Valley and Penn State?

“Cell selection is very much a Penn State story,” Liberti said. Centre County resident Emily Whitehead (and daughter of a Penn State employee) was the first pediatric patient in the world to receive CAR T-cell therapy for relapsed/refractory acute lymphoblastic leukemia. Emily has been cancer free for 10 years, thanks to the groundbreaking treatment she received.

“Penn State is graduating a lot of students to feed into the field of bioprocessing and biopharma — biomedical, materials science, bioengineering, biologics and chemical engineering — Penn State’s expertise is at the nexus of cell and gene therapy. It’s a microcosm of research, industry, and students all working in biotech and pharma.”

Now, with the first cGMP magnetic cell selection facility located right here in Innovation Park, he says that the time and the environment is right for more biotech and bioprocessing companies to build at Innovation Park.

“It’s a great place for it,” Liberti said. “We are among a group of world-class companies playing on the world stage. There is a lot of dialogue and interface between academic teams and industry. Happy Valley can be a strong player and center of excellence for the growing biotech and bioprocessing industry. We can be an industry leading force.”

Tags: biotech, Biotechnology, cell and gene therapy, cell therapy, construction management, facility, gene therapy, high-tech, Leveraged Design-Build, life sciences, mabs