Lotte Biologics is using virtual simulation technology to reduce risks that could arise when transferring the drug manufacturing process from its Syracuse plant, which handles small-scale production, to the large-scale production system in Songdo, while also fully launching its "Dual Site" strategy.
James Park, CEO of Lotte Biologics, held a press conference on Tuesday at the "BIO International Convention (BIO USA)" in San Diego, United States. "Now that Songdo Plant 1 has received approval for use, this is the real beginning from here," he said. "We will successfully transplant the quality competitiveness certified at Syracuse to the Songdo bio campus and open an era of high-quality, large-scale production." He added, "I think we should have one or two results by the end of this year," noting, "Securing commercial production contracts is our goal this year."
Park also expressed confidence that the first client to place an order could be a global big pharma company. "The Syracuse plant already has production experience with global clients and a quality track record," he said. "When Songdo's large-scale production capacity is added to this, the biggest competitive edge for clients will be the ability to proceed from early development to commercial production on a single platform."
Lotte Biologics plans to fully launch its "Dual Site" strategy, linking its Syracuse plant in New York with its Songdo plant in the United States. Under this structure, the Syracuse plant handles clinical trial drugs and small-scale production, while Songdo takes on large-scale commercial production. This allows clients to continue production under the same quality system from the early clinical stage through to commercial production, offering the advantage of reducing risks arising during the technology transfer process and securing supply chain stability.
Lotte Biologics is using computational fluid dynamics (CFD)-based process simulation technology to reduce the uncertainty of scale-up, considered the biggest challenge in the commercialization process. This is because, when expanding a process that succeeded at the laboratory scale to large-scale production facilities, the larger bioreactor size alters oxygen transfer, fluid flow and the physical stress on cells, which can lower productivity or create the risk of process failure. "Moving up the plant construction by about six months reflects that there is that much client demand," he said. "I am confident we will be able to announce order results soon."
