The single story, red brick building at 201 College Road East has been an enduring — if not architecturally dramatic — presence in the Princeton Forrestal Center and the Route 1 research corridor almost from the beginning.
In 1981 the biotech startup Cytogen, founded by Princeton venture capitalist Robert F. Johnston and one of the world’s first monoclonal antibody companies, moved into 201 College Road East. By 1999 Purdue Pharma moved into the site and it focused primarily on biopharma manufacturing and development. In about 2002 Purdue also started doing some contract manufacturing under the name Laureate BioPharmaceuticals.
In 2004, when Laureate was spun off as its own company to focused specifically on contract manufacturing for biopharmas, it still operated at the 201 College Road site. In 2006 Laureate announced plans to invest up to $9 million to expand the facility.
Now the door at 201 College Road East has a new logo. Last fall St. Louis-based Gallus BioPharmaceuticals, a contract manufacturing organization for process development and clinical and commercial mammalian cell culture- based biologics products, acquired Laureate, including 201 College Road East and its employees.
Amazingly — at least to those who think that the pharmaceutical industry is in a constant state of flux — Cytogen’s second product, Prostascint, a monoclonal antibody licensed in 1996, is still being manufactured at 201 College Road East by Gallus, doing work for a successor company to Cytogen. “The product originally licensed by Cytogen was sold to another company and that company still needed someone to manufacture it, and through all the connections, the product continued to be manufactured at this site,” says Jeffrey Strand, senior director, site operations, who has been with Gallus since its founding.
Gallus was founded by its president and chief executive officer, Mark Bamforth, who had previously spent 22 years at the large Boston-based pharmaceutical Genzyme, leaving as executive vice president. Bamforth had been sent to St. Louis to evaluate the possible purchase of a facility owned by Johnson & Johnson’s Centocor — which made Remicade, for rheumatoid arthritis and Crohn’s disease, and Stelara, for plaque psoriasis — but he eventually bought it for himself instead.
“He got to know the capabilities of the site and its management team and decided he had always had in his mind running a company of his own and saw the potential,” says Strand, referring to the St. Louis operation.
Bamforth got financial backing and officially started Gallus (the name is a Scottish word for “brilliant, amazing, or better than you could have imagined”) in 2011. Gallus’s majority investor is Ridgemont Equity Partners.
The acquisition of Laureate by Gallus, says Strand, made good business sense: Laureate had been doing contract manufacturing work for more than 12 years and had a strong customer base and a good technical reputation. “For Gallus, on day one, it quadrupled the number of development and early clinical customers we had. It advanced our revenue growth quickly,” he says. “We were also able to offer different services. This site has fill finish, the final filling of the product into the vials, which in St. Louis we had to contract out.”
The 201 College Road East facility, Strand adds, also has very talented employees and offers a location with a high density of pharma and biotech companies, giving Gallus close access to potential customers.
With the acquisition of Laureate, Gallus now has 350 employees, with 250 in St. Louis and about 100 in Princeton. “We have continued to grow the Princeton facility since the acquisition, about 15 percent, and are continuing to hire in parallel with our growing business,” Strand says.
When Gallus purchased Laureate, a minimal number of folks were displaced where there were redundancies of position, but the vast majority stayed as Gallus employees. The company’s scientists are primarily biochemists, molecular biologists, cell biologists, and analytical chemists.
According to the company website, “Gallus is a pure-play contract manufacturer, meaning it only offers contract manufacturing and doesn’t have any of its own products; it doesn’t compete with its customers.”
The biopharma products that Gallus manufactures treat a wide number of conditions. “Our customers range from top-10 pharma companies to small biotech startup companies with only a couple of employees and other size companies in between,” says Strand.
The manufacturing process at Gallus starts with the growing of the mammalian cells that produce the product — in bioreactors ranging in size from 50 to 2000 liters.
Next the product must be purified, because the target protein must be separated from the other proteins that the host cells normally produce. To do this, Gallus uses a process called column chromatography. The bottom of the column is packed with microscopic beads of resin; each bead includes a binding entity that sticks out and captures the product of interest; any proteins that do not bind to the resin will flow through and go to waste. Next the resin is washed with a buffer to remove anything not bound tightly to it. Finally, a product is sent through the column that will separate the desired protein from the resin in a highly purified state.
When Gallus takes on a project, its role in developing the manufacturing processes varies, depending on the customer’s needs, as Strand explains: “We have had customers who come in and say, ‘Here’s our process, here’s how you run it, and you need to transfer that process into manufacturing.’ We have customers who come in, and say, ‘Here is rough idea of what our process is, and we need you to further develop it and figure out how it should be done.’ And some say, ‘Here are our cells and it makes this product, and we need you to develop the entire manufacturing process and all the analytic methods needed to test it.’”
Strand explains that one factor differentiates Gallus from most of its competitors. “It is one of less than 10 companies worldwide that can provide CMO [contract manufacturing organization] biopharma services all the way from early development through commercial manufacturing,” he says. “There are a lot more companies that can do early development and clinical manufacturing but are not yet approved by regulatory agencies to do commercial manufacturing.”
Anyone who is approved to do commercial, he adds, is also approved for clinical and development manufacturing. But Strand explains that a manufacturing site that specializes in clinical and development but wants to get approved for commercial must invest significant time and money. As a result, companies that go to manufacturing organizations without commercial approval either end up working with that company to try to get them commercial approval or going somewhere else for commercial manufacturing. “In either case it is probably easier and faster to work with an organization that already has commercial approval,” says Strand.
At 201 College Road East, Gallus was able to lease a facility that already had the general infrastructure required for biopharmaceutical manufacturing. Says Strand: “The design of the facility needs to be appropriate to allow for appropriate segregation and flow of processes, materials, and personnel. Providing the appropriate environmental conditions for manufacturing is critical. In manufacturing areas, all of the air requires HEPA (high-efficiency particulate air) filtration at a high velocity to keep the environment clean. There must be separate air handlers for use in different areas to maintain segregation of operations.”
Water is another critical component. Not just any water. “The water used in the manufacturing process needs to meet standardized WFI (Water for Injection requirements),” says Strand. “Keeping the facility up to the highest technical standards requires on-going commitment with constant monitoring and oversight. Part of this commitment requires highly trained employees who have a strong background in facilities and quality requirements.”
For all these reasons, says Strand, “there is certainly a benefit to acquiring a functioning operational facility rather trying to add all of that capability to a location that had not been established for biopharmaceutical manufacturing.”
Strand, whose father was in sales for several different companies, was born in Chicago, and moved to Springfield, Illinois, during grade school. His mother is a nurse, and his parents still live in Springfield.
A pre-pharmacy and biology major at Augustana College in Illinois, Strand got his first job in St. Louis with Sigma-Aldrich, which manufactures and purifies proteins and enzymes, primarily for research purposes but also for pharmaceutical companies. “It was a great opportunity to learn all different aspects of biologics manufacturing, from cell culture and growing up cells to many different types of protein purification techniques to analytical methods and testing,” says Strand. “At Sigma it was not uncommon to be working on 15 to 20 different products in a year.”
During his eight and a half years at Sigma-Aldrich, Strand was a manufacturing biochemist, leading the teams that were performing small-scale to large-scale manufacturing. Going to school at night, he earned a master’s degree in molecular and cellular biology at the University of Missouri-St. Louis.
In 2000 he moved to Wyeth Biopharma, now part of Pfizer, which was housed at what is now the Gallus facility in St. Louis. In 2004, Johnson & Johnson’s Centocor division bought the facility from Wyeth, and Strand became senior manager of manufacturing for Johnson & Johnson, making Remicade, Stilera, and other clinical products in the J&J pipeline. He also spent some time as senior manager of quality assurance, which involved oversight of manufacturing operations for that facility to ensure that they were meeting all the requirements.
One of Strand’s responsibilities was the technical transfer of processes coming in and out of the site. Within large companies like these, manufacturing processes and analytical methods were either established or developed at other sites and needed to be transferred in or scaled up. Strand helped to ensure that the nuances of the manufacturing processes were exactly the same after the transfer.
“Equipment may not be exactly the same, and you have to work out parameters that still do the same process: that grow the cells as intended; purify the product as intended; and test the product as intended,” he says. “Looking back, the technical transfer of processes within a large organization like that is not that much different from being a contract manufacturing organization where you are transferring processes from other companies to here.”
Although most of Gallus’s clients are domestic, the company also has customers in Europe, Asia, Latin America, and Australia.
Gallus’s salespeople develop relationships with different biopharma companies. These include large pharma companies, which have large internal manufacturing capability but also do some outsourcing as part of their overall capacity strategy, down to small companies.
At 201 College Road East the company occupies 60,000 square feet, which Strand estimates is sufficient capacity for growth in the immediate future. Gallus also has a small warehouse in Monmouth Junction for the storage of supplies and equipment.
When Gallus acquired the Johnson & Johnson site in St. Louis, Strand became the director of program management, responsible for oversight of all the tech transfer processes that Gallus had with different companies. After the acquisition of Laureate in 2013, he was offered the new position of senior director of operations in Princeton, where he is responsible for daily operation of the site. He still commutes back to St. Louis on weekends to be with his wife and three children, who will be moving out here at the end of the school year.
Looking toward the future, Strand says, “The path forward for the company is, first of all, we plan to continue to grow the company organically through the existing sites and businesses we have, but Gallus continues to evaluate mergers and acquisitions of additional sites for additional potential growth.”
Gallus Biopharmaceuticals NJ LLC, 201 College Road East, Princeton 08540; 609-919-3400. Jeffrey Strand, senior director, site operations. www.gallusbiopharma.com.