“When SynCo was first established, we were mainly producing material for Phase III trials and the commercial market in our existing 1,500-L microbial fermentation-scale GMP facility,” says Joanne McCudden, business development manager. In order to grow the business, SynCo Bio Partners expanded its process and analytical development services to produce biopharmaceuticals for early-phase clinical trials, which require much smaller amounts of material. The new 5,000-sq-ft GMP facility, licensed by the EMEA in 2006, offers 300-L-scale microbial production or 200-L-scale mammalian cell batch or continuous production in wave bioreactors.
For microbial expression of recombinant proteins, SynCo has facilities with 100–1,500-L fermentation volumes, as well as smaller scale process development. Biosafety Level-2 laboratories allow vaccines and biodefense agents to be produced. For expression in Chinese hamster ovary cells and other mammalian cell lines, a stirred tank GMP bioreactor of 100 L and disposable bioreactors of 200 L generate harvest rates of up to 6,000 liters per month.
Four distinct downstream processing suites perform standard filtration, ultrafiltration, column chromatography, and preparative-scale HPLC. The fill-and-finish service can process up to 20,000 vials per batch, including aseptic filling and freeze drying of biopharmaceuticals for both clinical trials and market supply.
SynCo places key importance on project management. A program of process development and manufacturing can eventually involve around 100 different people, many of whom play backstage roles, but all who must understand the project goals and deliverables. SynCo has established a formal gated approach to project management, which aims to break the complexity of the overall manufacturing project into easily manageable pieces.
“We have an integrated service that can take clients from the early preclinical stage through clinical trials and to market launch. This service includes process development, scale up, and fill and finish of bulk product,” Lewin says.
In October 2006, Cleveland BioLabs, signed an agreement to transfer the technology for its lead product, Protectan CBLB502, to SynCo to produce sufficient amounts for clinical trials and the commercial market. Protectan CBLB502, a radioprotection molecule that has been shown to rescue test animals from radiation injury, could be stockpiled for biodefense purposes. SynCo will work with Cleveland BioLabs to develop the manufacturing process, based on completed pilot studies, and manufacture Protectan CBLB502 under GMP standards for Phase I testing.
As a potential biodefense product, Protectan CBLB502 is on a fast track to market, and the SynCo facility is capable of producing large quantities for stockpiling. “It was incredibly important to Cleveland BioLabs to find someone with existing experience in manufacturing for the market,” says McCudden. Moreover, Cleveland BioLabs “did not want to work with someone who had to share the learning curve with them,” she adds.
Besides Cleveland BioLabs, SynCo serves other customers in the U. S. About three-quarters of the company’s revenues come from U.S. clients, and the rest largely from European companies. Customers are attracted to SynCo Bio Partners because “we are robust, established with a good track record, and we’ve been profitable for the past seven years,” says Lewin. In fact, the company has orders booked for the next four years.
SynCo is looking to expand to other manufacturing locations as a result of its success in attracting new clients, as well as being able to form strong, long-term, and mutually beneficial relationships with existing clients. The details of SynCo’s expansion plans have not yet been finalized but whatever the outcome, “growth is definitely on the agenda,” Lewin says.