Lotte Biologics signaled a shake-up in the global contract development and manufacturing organization (CDMO) market by securing approval for use of its Bio Campus Plant 1 in Songdo, Incheon.
The company aims to finish preparations for commercial production by the end of the year, pulling the schedule forward by about six months from the original plan.
With "ultra-fast hardware setup" and "software technology transfer based on virtual simulation" as twin engines, the strategy is to quickly narrow the gap with the front-runners.
Chief Executive James Park of Lotte Biologics on the 23rd (local time) held a briefing with Korean reporters at Bio USA in San Diego, California, saying, "On the 22nd, we received approval for use of the Songdo Plant 1 (total capacity 120,000 liters)," and "It is a result achieved exactly two years after groundbreaking, shortening the typical build time for a biomanufacturing facility by more than a year and a half."
The shortened timeline was driven by global customers' demand for early operation. Park emphasized, "It is not just that we finished construction quickly; it is the result of concentrating the company's capabilities to proactively respond to inquiries from potential global customers asking 'when will the plant be ready?'"
Lotte Biologics plans to bring forward the "GMP-ready (completion of facility and quality systems for drug manufacturing)" milestone, originally slated for the second quarter of next year, to the end of this year after commissioning and qualification in the second half. Following a large-scale completion ceremony in Nov., the "dual-site" system linking Syracuse (clinical and ADC) in the United States and Songdo in Korea (large-scale commercial production) will come clearly into view for full operation.
◇ Syracuse know-how and "spare capa" as weapons… "Targeting major orders within the year"
Some in the market have cast a questioning eye on Lotte Biologics' quality and operational capabilities because it is a latecomer. Park expressed his determination to tackle this head-on with the Syracuse plant's "more than 20 years of commercial production track record."
He said seasoned personnel in Syracuse are stationed on-site in Songdo conducting training, and Songdo staff are also dispatched to Syracuse through a rotation program to fundamentally block quality risks.
Park also stressed there is "flexibility" that only a latecomer can have. He said, "Existing large CDMO corporations already have saturated capacity, making it hard to respond to customers' abrupt schedule changes, but since we are in the initial ramp-up phase, we can leverage our spare capa (capacity) to provide a customized setup."
He also assessed the rapidly changing market conditions as positive. Park said that inquiries from global big pharma seeking alternatives to Chinese corporations are continuing following implementation of the U.S. biosecurity law, adding, "We expect to win one or two major orders by the end of the year."
◇ From lab to large bioreactors… ensuring process stability through simulation
If the hardware was prepared at ultra-fast speed, the software is aiming for a "0% failure rate." Chief Technology Officer Han Jae-jun of Lotte Biologics unveiled a process simulation strategy using computational fluid dynamics (CFD) to visitors at the Bio USA booth that day.
The "scale-up" stage of expanding a lab-scale process to large bioreactors with tens of thousands of liters carries a high risk of process failure because cells can be stressed by flow patterns or oxygen supply imbalances. Lotte Biologics introduced CFD technology in the process of transferring a validated commercial process from Syracuse's 5 kL bioreactor to Songdo's 15 kL large bioreactor.
Han said, "We precisely analyzed data such as shear stress and oxygen transfer rate (OTR) in a virtual environment, which are difficult to verify through experiments alone," adding, "Based on this, we precisely designed a 500-liter pilot bioreactor as a scaled-down model to maximize similarity with the actual commercial production environment."
He added that, in line with the recent high-titer trend in biopharmaceuticals, the company also completed additional investment to significantly expand downstream (DSP) capacity responsible for purification processes.
◇ Focusing on what it "does well" in CMO and ADC… IPO to start after reaching orbit
Lotte Biologics plans to pursue a "selection and concentration" strategy to secure an early foothold in the market. The company will refrain from expanding into contract development (CDO) or contract research (CRO) and focus on strengthening capabilities in large-scale commercial contract manufacturing (CMO) and Antibody-Drug Conjugate (ADC) production. With land already secured within the Songdo site for expansion of Plants 2 and 3, the plan is to respond flexibly to market demand.
Park, citing his past experience successfully leading an initial public offering (IPO) on the main board while at Samsung Biologics, also hinted at a future listing blueprint. He said, "I want to replicate that formula for success here at Lotte Biologics," adding, "We will grow into a trusted partner for the market, so please watch as the full-fledged 'Songdo era' unfolds."