Cellaris, Seoul National University Hospital to Test Automated Cell Therapy Manufacturing … Second Asian Deal in Two Weeks

Cellaris, a U.S. company specializing in automated cell therapy manufacturing, has signed an agreement with Seoul National University Hospital to test automation of a genetically modified hematopoietic stem cell manufacturing process.

According to U.S. pharmaceutical trade publication Fierce Pharma on the 24th (local time), Cellaris will work with Seoul National University Hospital as an integrated development and manufacturing organization (IDMO) to assess whether the hospital’s process can be adapted to its automated manufacturing platform, Cell Shuttle. Financial terms were not disclosed.

Seoul National University Hospital will test the technology with an investigational cell therapy targeting paroxysmal nocturnal hemoglobinuria (PNH). The manufacturing test will use a two-step transfection process with an electroporator built into Cell Shuttle.

Electroporation uses electrical pulses to temporarily create pores in cell membranes, while transfection is the process of introducing genetic material and other substances into cells. Cellaris’ electroporator is integrated into a single-use cartridge and automates multiple steps in the manufacturing process.

Cellaris CEO Fabian Gerlinghaus said in an interview that the test aims to develop an automated manufacturing strategy to support the future U.S. clinical development of Seoul National University Hospital’s PNH candidate.

The agreement, like the contract Cellaris signed last week with Taiwan’s Genome Frontier Therapeutics, focuses on transfection and electroporation. Gerlinghaus said the two organizations’ nonviral cell therapy programs “require sophisticated electroporation processes,” which he described as a key differentiator for Cell Shuttle.

He said Cell Shuttle is “the only end-to-end cell therapy manufacturing platform with built-in electroporation capabilities that has been validated in the clinic.” He added that the first patient dosing with partner Cabaletta Bio in April this year is an example of this validation.

Gerlinghaus said the dosing milestone helped more than double the customer base since the start of this year. “We signed contracts with 12 customers this year,” he said, adding, “We’ll maintain this pace and build a substantial portfolio.”

Meanwhile, Cellaris cut jobs in California and New Jersey this summer after losing a major pharmaceutical customer. That customer was Bristol Myers Squibb (BMS), which in 2024 signed a Cell Shuttle manufacturing capacity agreement worth up to $380 million.

“BMS was just one of several customers,” Gerlinghaus said, adding that BMS later “made public statements that we strongly disputed.” He challenged BMS’ assessment that Cell Shuttle did not meet the requirements for commercial manufacturing of the approved CAR-T therapy Breyanzi.

Gerlinghaus said the BMS program “ended before it generated comparability data to submit to the U.S. Food and Drug Administration (FDA)” and that “the FDA has never made a comparability determination for Breyanzi.” He nevertheless said, “Our strategy is unchanged.”