The combination of disposable technology, contract manufacturing capabilities, and a development partner has led specialty biopharma Itero, in San Mateo, CA, to join forces with opposite-coast biomolecule developer, manufacturer and equipment maker Xcellerex. Itero's focus is clinically and commercially differentiated protein molecules that serve niche markets.
"The reason we chose Xcellerex was our synergy," says Bryan Lawlis, Itero president and CEO. "It has capabilities in manufacturing and technology; we have the other aspects of drug development expertise, on the clinical development side."
Lawlis knows biomanufacturing, from 15 years with Genentech, culminating in VP for process sciences. "I'm looking for ways to shorten development timelines," he says, of the appeal of partnering with Xcellerex and using disposable technology.
It's becoming an oft-repeated refrain: Use of traditional stainless steel equipment yields long start-up and validation times and high costs. "Disposables circumvent that," Lawlis says. "And the FDA likes it. There are fewer mistakes around the cleaning of tanks and sterilization."
Under the partnership, which has effectively already begun with Xcellerex's receipt of cell lines from Itero, Xcellerex "will use its PDMax process development platform and its FlexFactory disposable technology to provide Itero a cost-effective and flexible manufacturing alternative at full commercial scale," says CEO Joseph Zakrzewski.
The part cash, part equity arrangement is built around Itero's lead product candidate, an undisclosed therapeutic protein, "this is our second molecule," says Zakrzewski, referring to an Xcellerex vaccine candidate.
"This is creative dealmaking," he says. "That's what it takes. We're drug developers running 24/7," and not just a developer, a CMO, or an equipment maker. "We're going to do a lot more of this stuff."
- here's the announcement