Lotte Biologics: "No Issues With 'GMP-Ready' in November"... Songdo CDMO Competition Begins

Validation Procedures Underway for Production System
On Track for GMP-Ready in November
Outpaced by Samsung Bioepis in Capacity and Track Record
"Distinction Through U.S. Experience and Expertise"

Lotte Biologics is accelerating final preparations at its Incheon Songdo Plant 1 ahead of reaching 'GMP-Ready' status in November. Once the plant is fully operational next year, a new contender with a production capacity of over 100,000 liters will enter the domestic large-scale biopharmaceutical contract development and manufacturing (CDMO) market, which Samsung Bioepis has effectively dominated. With Celltrion also actively seeking to secure customers by running external CDMO business alongside its in-house biopharmaceutical production, competition among Songdo-based CDMOs is expected to become even fiercer.

Aerial view of Lotter Biologics Incheon Songdo Bio Campus Plant 1. Lotter Biologics

According to industry sources on September 23, Lotte Biologics is currently conducting trial runs and validation on core equipment at its Incheon Yeonsu-gu Songdo Bio Campus Plant 1. This phase ensures that the facilities and systems are running properly and are prepared for production in compliance with Good Manufacturing Practice (GMP) standards. If all procedures are completed without issue, Lotte Biologics will achieve GMP-Ready status in November, as initially planned, meaning the site will be prepared to manufacture products for client companies.

A Lotte Biologics representative stated, "Although no contracts have been finalized yet, discussions are ongoing, with potential clients visiting the Songdo plant to tour the facilities," adding, "There is no change to our schedule to complete GMP-Ready by November."

Taking on '845,000 Liters' Samsung Bioepis... Significant Gap Remains in Scale

With Lotte Biologics' first domestic manufacturing facility approaching operation, attention is focused on the competitive landscape of the Korean large-scale CDMO market. Samsung Bioepis is considered its main competitor, as a 'pure-play' CDMO company focused on servicing external clients. While Celltrion is also running a CDMO business using its existing manufacturing infrastructure, its business strategy differs as it primarily focuses on manufacturing proprietary drugs such as Remsima and Yuflyma.

In terms of simple production volume and order records, it is challenging for Lotte Biologics to narrow the gap with Samsung Bioepis in a short period of time. Currently, Samsung Bioepis has a domestic production capacity of 785,000 liters. Adding its newly acquired manufacturing facility in Rockville, Maryland (60,000 liters), brings its total production capacity to 845,000 liters. In contrast, even when taking into account Lotte Biologics' planned expansion with Songdo Plants 2 and 3, its domestic production capacity is estimated at around 360,000 liters.

Particularly in the CDMO industry, where accumulated order performance and client trust with global pharmaceutical companies are critical, the entry barriers for latecomers are even higher. An industry source noted, "CDMO is not a market where clients switch manufacturing partners just because of lower unit costs or larger facility size," adding, "If a new player wants to secure clients, they must offer clear differentiation in terms of technology or services that incumbents do not provide."

Lotte Biologics: "Competing With U.S. Network and Talent"

Lotte Biologics is seeking to differentiate itself by leveraging manufacturing experience and expertise gained in the United States—a first among Korean companies. In its first year after establishment in 2022, Lotte Biologics acquired and began operating a biologics plant from global pharmaceutical company Bristol Myers Squibb (BMS) in Syracuse, New York. At the time of acquisition, the company addressed the usual lack of experience facing new firms by inheriting more than 99% of BMS's existing employees, including key personnel with an average of over 15 years of biopharmaceutical experience.

Lotte Biologics plans to bridge its U.S. business base with Songdo Plant 1 to overcome the limitations of a late entrant. Its 'dual-site' strategy involves first securing early-stage or clinical-phase projects in Syracuse, then transferring production to Songdo once products advance to commercial-scale manufacturing. A Lotte Biologics official said, "The essence of the dual-site model is to connect clients acquired in Syracuse with large-scale commercial manufacturing in Songdo," adding, "Our plan is to create synergy by linking client development in the United States with large-scale operations at our Songdo plant."

This content was produced with the assistance of AI translation services.