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LOTTE BIOLOGICS provides GMP manufacturing services for biopharmaceuticals, operating a Syracuse, NY campus with a total bioreactor capacity of 40,000 L (eight 5,000 L stainless steel bioreactors) and extensive QC labs and warehousing, supported by regulatory approvals worldwide. The company is expanding into Antibody-Drug Conjugates (ADC) with on-site drug substance production and conjugation, backed by over $100 million invested in ADC modalities, offering an end-to-end service from drug substance manufacturing to ADC conjugation. Looking ahead, it is constructing three advanced bio plants in Songdo, South Korea, each with eight 15,000 L bioreactors plus additional 3,000 L units to support clinical production, aiming for a combined bioreactor capacity exceeding 360,000 L. The overall goal is to become a top-tier global CDMO in the biopharmaceutical industry, delivering therapies to patients worldwide.
Industries
Industrial & Manufacturing
Biotechnology
Healthcare
Company Size
501-1,000
Company Stage
Growth Equity (Non-Venture Capital)
Total Funding
$214.1M
Headquarters
Seoul, South Korea
Founded
N/A
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Total Funding
$214.1M
Above
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Funded Over
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CDMO capacity: stainless by volume, single-use by number. Large stainless-steel projects are rising, but pipeline demand is increasingly moving toward smaller, more flexible manufacturing models. September 15, 2026 Contributing Writer At Sartorius' Process Intensification Forum in Hyderabad, India in June, Miriam Monge, the bioprocess firm's head of Customer and Industry Advocacy, questioned the billions being spent on large stainless-steel capacity across the industry. She highlighted North Carolina, where contract development and manufacturing organization (CDMO) Fujifilm Biotechnologies has opened the first phase of a $3.2 billion site with eight 20,000-liter bioreactors, and Amgen and Genentech have committed a further $1 billion and $2 billion respectively nearby. As such, Monge asked delegates whether capacity on that scale could ever be filled, and whether the local grid and water supply could feed several plants of that capacity in one region. And North Carolina is not alone. A run of large stainless-steel projects has been announced by - specifically - CDMOs elsewhere. Among them Lonza, which is adding six 20,000-liter bioreactors at its headquarters and manufacturing center in Visp, Switzerland; Samsung Biologics, which has built a fifth plant at its Songdo site in South Korea for around $1.5 billion, adding 180,000 liters across twelve 15,000-liter bioreactors; and Lotte Biologics, whose $3.3 billion Songdo Bio Campus will run three plants of eight 15,000-liter stainless-steel bioreactors each, the first due in 2027. Beyond the headlines, it is important to put these news stories in context, according to Dawn Ecker, Managing Director of bioTRAK Database Services at the BioProcess Technology Group, a division of BDO USA. The industry holds about 8.6 million liters of installed bioreactor capacity, with roughly 35% of it run by CDMOs, she told us. By 2030, the total is expected to grow to 10.6 million liters, with nearly half the new capacity - around 915,000 liters - installed by CDMOs. Of that new CDMO capacity, 71% by volume is large-scale stainless steel, she said, but this is being installed by just a handful of companies. When looking at the number of systems, single-use leads, making up 61% of the roughly 120 bioreactors CDMOs are projected to install. The quiet rise of single-use capacity. The single-use build-out is less headline-happy than that of a billion-dollar stainless campus, so it often runs under the radar. Some of the larger examples include WuXi Biologics, which has built up a large single-use based network (including running twelve 4,000-liter single-use bioreactors at its Dundalk site in Ireland); AGC Biologics doubling its single-use capacity in Copenhagen; and Fujifilm, stainless in North Carolina, going single-use in the UK at Teesside. The quieter single-use investments reflect demand moving toward smaller volumes, said Ecker. The share of pipeline products that could be made in a single 2,000-liter bioreactor has risen from 42% in 2021 to 55% today, and among those products the proportion outsourced has risen from 38% to 43% over the same period. "Demand fragmenting is present in the CDMO data," and the trend is expected to continue, she said. Despite this, the large steel plants are not necessarily under-utilized. Ecker was wary of giving utilization specifics but said the market is mostly full. CDMOs do not announce capacity they cannot fill, she noted, because utilization is their main revenue. "Over a quarter of all CDMOs are expanding," she said, "so I would say overall we are mostly full rather than mostly underused." In her experience, expansion talk starts once a site has been booked above 80% for several years running. Scale, of course, is driven by product volume demand. Products above roughly 350,000 liters a year still favor a 20,000-liter stainless line, and those below 20,000 liters suit single-use. The middle, 20,000 to 350,000 liters a year, is harder to define now that single-use runs beyond the one-time ceiling of 2,000 liter bags, and up to 6,000 liters. "As an example, if we estimate that a product has an annual volumetric demand of 180,000 liters per year, we know we could run nine batches in a 20,000 liter reactor and meet demand. But we also know that we could manufacture 180,000 liters per year in single use," she said, either from a bank of 2,000-liter single-use reactors or a smaller number of 5,000 or 6,000-liter ones, depending on the product's cost of goods and whether the capacity is free. Furthermore, intensified processes could reach the same output from smaller equipment again. "As an industry, we keep improving our manufacturing processes for new products - whether that be increasing our titers and process yields or employing N-1 strategies," said Ecker. "The whole idea is to make more in (and with) less - less space, less media, smaller or fewer batches." Based on bioTRAK's numbers, Monge's question goes from rhetorical to measurable. The big stainless plants are largely justified for the high-volume products and the handful of firms building them, while most of the market, and most of the pipeline it now serves, is heading toward smaller, single-use, and more flexible capacity. Dan Stanton is a journalist with 15 years' experience covering bioprocessing and biomanufacturing. He currently works as an editorial specialist at Sartorius. Topics.
Lotte Group transforms business focus toward bio, AI, and hydrogen innovations. Key points. * Lotte Group is transitioning from petrochemicals to bio, AI, and hydrogen. * A new 120,000-liter antibody drug plant in Incheon is fully operational. * Utilization of AI circuit foil production has significantly increased. * LotteSK Eneroot aims to complete an 80MW hydrogen project by year-end. Lotte Group, a prominent South Korean conglomerate, is steering its core business strategy away from traditional petrochemicals and embracing innovations in bio, artificial intelligence (AI), and hydrogen sectors. This transformation is gaining momentum as the company reports significant developments in these areas throughout 2026. The announcement includes the completion of a major antibody drug manufacturing facility at the Lotte Biologics Songdo Campus in Incheon. This new plant, capable of producing 120,000 liters, features eight state-of-the-art 15,000-liter bioreactors and is poised to play a crucial role in the contract development and manufacturing organization (CDMO) space. It aims to aid pharmaceutical companies in producing drugs more efficiently and is expected to achieve good manufacturing practice (GMP) certification ahead of schedule, which is vital for securing commercial orders. In addition to advancements in biopharmaceuticals, Lotte Group is also seeing a robust demand for high-volume low-profile (HVLP) copper foil used in AI data centers. This demand has led to an increase in production capabilities at their Iksan plant, with plans to expand the output from 3,700 tons to 16,000 tons by 2027. The impressive rise in utilization rates for AI circuit foil production - from 45% to 67% - underscores the growing importance of AI technologies within their business structure. Hydrogen initiatives are also a key component of Lotte's strategic pivot. LotteSK Eneroot, a partnership involving Lotte Chemical and Air Liquide Korea, has made significant strides in the hydrogen power sector. The company has initiated commercial operations of its first 20MW hydrogen power plant in April 2026. This facility supplies byproduct hydrogen from associated companies and uses petrochemical byproducts as fuel for energy production. The overarching objective is to complete a total of 80MW of hydrogen capacity by the end of the year. Furthermore, Lotte Group's expansion is not limited to the energy and biopharmaceutical sectors. The conglomerate has formed a joint venture between its food divisions in Korea and Japan, consolidating operations into a single entity in Singapore to unify decision-making and enhance growth opportunities in Asian markets. This initiative is viewed as a strategic response to slowing domestic market growth, with hopes of leveraging overseas sales to drive revenue. Overall, Lotte Group's strategic shift towards biopharmaceuticals, AI, and hydrogen presents a positive outlook for the company's future, reflecting their commitment to innovation and adaptation in a rapidly changing global economy. July 31, 2026 at 10:11 AM Incheon, South Korea
LOTTE Biologics completes construction of Songdo Bio Campus Plant 1 and obtains approval for use. 2026-06-22 08:00 446 INCHEON, South Korea and SAN DIEGO, June 22, 2026 /PRNewswire/ - LOTTE Biologics announced that it has completed major construction and obtained approval for use for Plant 1 at its Songdo Bio Campus in Incheon, South Korea. [Picture] LOTTE Biologics Songdo Bio Campus Factory 1 The milestone was achieved approximately two years after the start of construction in 2024, representing an exceptionally fast project execution timeline among global biologics manufacturing facility construction projects. The approval for use confirms that the physical construction of the facility has been completed, including site development, building and civil engineering works, production equipment, piping, electrical systems, and control systems. As biologics manufacturing facilities must support complex cell culture processes while meeting global cGMP standards, their construction requires advanced design and engineering capabilities as well as systematic quality management. LOTTE Biologics incorporated operational experience and manufacturing know-how from its Syracuse Bio Campus into the construction of Songdo Plant 1. From the design stage, the company implemented an automated Manufacturing Control System, or MCS, to enhance production efficiency and quality competitiveness. The facility has also been designed to maximize the company's ability to provide customized support for customers during future commercial manufacturing. Songdo Plant 1 is a 120,000-liter antibody manufacturing facility, equipped with eight 15,000-liter stainless-steel bioreactors to support large-scale commercial production demand. The facility also incorporates advanced bioprocessing technologies, including higher-titer cell culture and perfusion processes. In addition, LOTTE Biologics introduced an automated warehouse and real-time monitoring-based operating systems to improve manufacturing stability and operational efficiency. Through its dual-site strategy linking Songdo Bio Campus with Syracuse Bio Campus in New York, the United States, LOTTE Biologics is now positioned to provide integrated CDMO services that connect early-stage clinical production with large-scale commercial manufacturing. Under this model, the Syracuse Bio Campus will support early-stage customer projects and clinical supply, while Songdo Plant 1 will serve as a large-scale commercial manufacturing base. This dual-site structure enables the company to respond flexibly to a broad range of customer needs, from small-scale projects to large commercial production volumes. Based on its manufacturing network spanning the United States and Korea, LOTTE Biologics anticipates enhanced support for customers' regional supply strategies and growing demand for supply chain risk diversification. LOTTE Biologics plans to begin full-scale commissioning and production system validation in the second half of this year. Through these efforts, the company aims to secure GMP manufacturing readiness early and establish a stable foundation for commercial manufacturing to meet global customer demand. The company also plans to continue strengthening production efficiency and quality competitiveness through data-driven process operations and advanced digital systems. "Completing major construction and obtaining use approval for Songdo Plant 1 approximately two years after groundbreaking is the result of our employees' capabilities, dedicated project execution, and strategic support and collaboration across the LOTTE Group," said James Park, CEO of LOTTE Biologics. "Based on our global manufacturing platform connecting Syracuse and Songdo, we will establish ourselves as a trusted CDMO partner for customers worldwide." He added, "With an integrated manufacturing system that combines speed, quality, and production flexibility, we will proactively respond to the diverse development and commercialization needs of global customers and continue growing into a world-class CDMO company."
LOTTE Biologics has completed construction of Plant 1 at its Songdo Bio Campus in Incheon, South Korea, and obtained approval for use approximately two years after breaking ground in 2024. The 120,000-litre antibody manufacturing facility features eight 15,000-litre stainless-steel bioreactors for large-scale commercial production. It incorporates an automated Manufacturing Control System, advanced bioprocessing technologies, and real-time monitoring systems to enhance efficiency and quality. The facility will work alongside LOTTE Biologics' Syracuse Bio Campus in New York, with Syracuse handling early-stage clinical production and Songdo focusing on large-scale commercial manufacturing. This dual-site strategy enables the company to serve customers across development stages and support regional supply diversification. LOTTE Biologics plans to begin commissioning and validation in the second half of this year.
LOTTE Biologics implements ValGenesis e-Logbook solution to modernize QC operations. SANTA CLARA, Calif., March 17, 2026 - ValGenesis, Inc., the global leader in enterprise digital validation and compliance solutions, today announced that LOTTE Biologics, a rapidly growing contract development and manufacturing organization (CDMO) headquartered in Seoul, South Korea, has successfully gone live with the ValGenesis e-Logbook solution. The digital logbook management tool transforms operational execution in regulated environments with complete traceability and control. Founded in 2022, LOTTE Biologics entered the pharmaceutical industry with the ambition of becoming a leading global CDMO. The company operates a Bio Campus in Syracuse, New York, and is nearing completion on the construction of a state-of-the-art Bio Campus in Songdo, South Korea, where it is operating a satellite quality control (QC) lab as a precursor to the main facility. As part of its digital transformation journey, LOTTE Biologics has implemented ValGenesis in its satellite QC lab, with plans to extend the platform across its main laboratory and production facilities in the upcoming Songdo Bio Campus. The go-live represents a major milestone in building a fully digital and connected quality ecosystem across the organization. LOTTE Biologics intends to solidify their digital foundation through the implementation and enhancement of enterprise systems, including LIMS, EAM, and EDMS, to support seamless data flow, strengthen consistency, and improve overall operational efficiency. The company is also exploring instrument data automation via the ValGenesis Gateway, which enables direct data capture from laboratory instruments, reducing manual effort, improving accuracy, and providing real-time insights for faster decision-making. The solution replaces paper-based logbooks with real-time digital forms accessible across devices. It supports QR and barcode-based form selection, offline data capture, and no-code configuration to align with standard operating procedures (SOPs). The ValGenesis e-Logbook system ensures regulatory compliance through role-based access, timestamped audit trails, and automated review workflows, and it delivers enterprise-wide visibility when integrated with MES, QMS, LIMS, and CMMS systems. "This project represents more than just a system implementation - it marks a meaningful transformation for LOTTE Biologics," said Hyunjin Cho, IT Team, LOTTE Biologics. "By replacing paper-heavy QC processes with streamlined digital workflows, we have built a more efficient, reliable, and scalable environment that enhances quality management and prepares us for future growth." "We are proud to partner with LOTTE Biologics on this journey toward digital excellence," said Terrance Blackwell, Chief Delivery Officer at ValGenesis, Inc. "The successful go-live underscores our shared commitment to innovation, data integrity, and operational efficiency. With this milestone, LOTTE Biologics takes an important step toward building a fully digital, automated, and compliant R&D-to-manufacturing ecosystem - supporting its vision to become a global leader in biopharmaceutical development and manufacturing." About LOTTE Biologics LOTTE Biologics is a contract development & manufacturing organization (CMDO) delivering integrated biologics and bioconjugate services across the full product lifecycle. Their capabilities encompass phase-appropriate DS manufacturing for mammalian-cell-based biologics, including monoclonal antibodies, fusion proteins, multi-specifics, and integrated ADC manufacturing. Guided by the vision "Possibilities Beyond Limits," LOTTE Biologics works alongside innovators of all sizes to enable efficient scale-up, dependable execution, and the advancement of transformative therapeutic programs. For more information visit: https://www.lottebiologics.com/en About ValGenesis Inc. ValGenesis, Inc., is the global leader in enterprise digital validation. Serving the life sciences industry for nearly two decades, ValGenesis enables companies to digitize their commissioning, qualification, and validation processes through its AI-enabled ValGenesis Smart GxP(TM) platform, which includes solutions for risk management, cleaning validation, continued process verification, and CMC development. ValGenesis helps customers worldwide reduce costs, improve compliance, and accelerate innovation. For more information visit: https://www.valgenesis.com/ For further information, contact: Althea D'Sylva, ValGenesis Communications, +1 510-445-0505 Ex.1026 [email protected] LOTTE Biologics Media Contacts: Baeklae Jo | [email protected] Sangho Lee | [email protected] Kihong Kim | [email protected]
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Industries
Industrial & Manufacturing
Biotechnology
Healthcare
Company Size
501-1,000
Company Stage
Growth Equity (Non-Venture Capital)
Total Funding
$214.1M
Headquarters
Seoul, South Korea
Founded
N/A
Find jobs on Simplify and start your career today