LOTTE Biologics

What LOTTE Biologics does

LOTTE Biologics is a South Korea-based contract development and manufacturing organization (CDMO) for biopharmaceuticals, established in 2022 as a subsidiary of Lotte Group and headquartered in Seoul. The company provides end-to-end services spanning cell line development, upstream/downstream processing, antibody-drug conjugate (ADC) conjugation, analytical testing, and cGMP manufacturing for clinical and commercial drug substance production. Its service portfolio is organized across four primary streams: Contract Development (CDO), Contract Manufacturing (CMO), Analytical Testing, and ADC Conjugation Services, all delivered under project-based B2B contracts negotiated on a per-molecule basis.

The company's operating footprint centers on two manufacturing campuses: the Syracuse Bio Campus in New York (40,000L operational capacity across eight 5,000L stainless-steel bioreactors, 62+ regulatory approvals from FDA/EMA/PMDA/MFDS) and the Songdo Bio Campus in Incheon, Korea (Plant 1 at 120,000L approved for use in June 2026 with full commissioning in H2 2026, scaling toward a planned 360,000L total). Its technology stack includes proprietary assets such as the SoluFlex Link™ hydrophilic ADC linker platform co-developed with Kanaph Therapeutics, one-stop ADC services under one roof at Syracuse (100L-1,000L single-use reactors with OEL target of 10ng/m³), and the ValGenesis e-Logbook digital QC platform.

Commercially, LOTTE Biologics generates revenue through negotiated project-based CDMO contracts with global biopharmaceutical companies and clinical-stage biotechs (named customers include Ottimo Pharma, Rakuten Medical, Kanaph Therapeutics, a Japan-based global pharmaceutical company, and an undisclosed US oncology biotech firm). Go-to-market is direct enterprise field sales supplemented by heavy participation at partnering events such as BIO International Convention, DCAT Week, CPHI, and Bio Japan. The company is targeting an eventual IPO in Korea and is positioned by its parent Lotte Group as a strategic growth priority within the conglomerate's portfolio restructuring away from petrochemicals toward biopharmaceuticals and specialty materials.

Name

LOTTE Biologics

Legal name

LOTTE BIOLOGICS

Website

https://lottebiologics.com

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

501–1,000 employees

Short description

LOTTE Biologics is a South Korea-based CDMO subsidiary of Lotte Group, founded in 2022, providing end-to-end biopharmaceutical contract development, manufacturing, analytical testing, and ADC conjugation services from dual operational sites in Syracuse, NY and Songdo, Korea, serving global biotech and pharma clients.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Contract Development and Manufacturing (CDMO)

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731), Biological Products, (No Disgnostic Substances) (2836), Services-Testing Laboratories (8734)

akta.pro primary industry

Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)

akta.pro secondary industries

Drug Substance–Drug Product Integrated CDMO (HLAGABAG), Biologic API/Drug Substance Manufacturing Services (HLAAAKAA), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

Keywords

• Biopharmaceutical CDMO services
• Antibody contract manufacturing
• ADC conjugation services
• Cell line development
• Analytical quality testing

Headquarters

HQ city

Seoul

HQ country

South Korea

HQ region

Asia

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Infrastructure, Personnel, Technology or R&D, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Contract Manufacturing (CMO): LOTTE Biologics earns revenue by providing cGMP manufacturing services for clinical and commercial biological drug substance production at its Syracuse and Songdo facilities. Manufacturing contracts are project-based, with clients engaging the company for specific production runs, technology transfers, and process validation batches. Revenue is recognized as manufacturing milestones are achieved.
2. Contract Development (CDO): Revenue generated from cell line development, process development, optimization, characterization, and technology transfer services. The company leverages partnerships with firms like Asimov and ExcellGene for cell line development while providing MS&T (Manufacturing Science and Technology) services internally. Development contracts span from early-stage molecule characterization through commercial process validation.
3. Analytical Testing Services: Quality control testing services including analytical tech transfer, in-process testing, finished product release testing, and stability testing. These services are offered as standalone analytical engagements or bundled with CDO/CMO contracts, providing a recurring revenue stream aligned with client manufacturing timelines.
4. ADC Conjugation Services: Specialized ADC manufacturing and development services at the dedicated Syracuse ADC facility, handling high-potency bioconjugation from 100L to 1,000L single-use reactors. Revenue is generated through process development and cGMP manufacturing contracts for ADC drug substances.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels6 records

Core offering

LOTTE Biologics is a Contract Development and Manufacturing Organization (CDMO) providing end-to-end biopharmaceutical services spanning cell line development, cGMP clinical and commercial manufacturing of biological drug substance, antibody-drug conjugate (ADC) conjugation, and analytical quality testing. The company operates dual manufacturing campuses — Syracuse (New York, USA, 40,000L operational) and Songdo (Incheon, Korea, 360,000L planned) — and serves global biotech and pharmaceutical clients seeking outsourced biologics development and manufacturing capacity.

Differentiator

Problem solved

Functional benefit

Brands

• SoluFlex Link: Proprietary hydrophilic linker platform for ADC (antibody-drug conjugate) technology developed in collaboration with Kanaph Therapeutics.

Products and services

• CDO (Contract Development) Services Development service capabilities across the product life cycle, including product launches, scale-down process verification, and technology transfers. Offered to pharmaceutical and biotech clients needing outsourced cell line development, process development, optimization, characterization, and tech transfer for biological drug substances.
• CMO (Contract Manufacturing) Services cGMP manufacturing services for the clinical and commercial supply of biological Drug Substance. Production runs from clinical through commercial scales using eight 5,000L stainless-steel bioreactors at Syracuse (40,000L) and planned 120,000L at Songdo Plant 1 (eight 15,000L bioreactors).
• Analytical Testing Services Quality control testing services including analytical tech transfer, in-process testing, finished product testing, and stability testing. Offered standalone or bundled with CDO/CMO contracts, providing a recurring revenue stream aligned with client manufacturing timelines.
• ADC Conjugation Services One-stop ADC conjugation services combining monoclonal antibody production (5,000L/1,000L scale) with bioconjugation and high-potency API handling (OEL target: 10ng/m³) at single-use reactors from 100L to 1,000L. Includes cell line development, antibody production, bioconjugation, process development, and QC under one roof.
• SoluFlex Link™ ADC Linker Platform Proprietary hydrophilic linker platform for antibody-drug conjugate development designed to improve ADC stability, solubility, and therapeutic index. Addresses limitations of conventional linker approaches and supports consistent product quality during storage and distribution. Validated through internal research presented at AACR 2026 demonstrating reduced aggregation and enhanced anti-tumor efficacy at lower concentrations vs. conventional linkers.

Quantifiable outcome

• 62+ manufacturing approvals from global regulatory authorities (FDA, EMA, PMDA, MFDS)
• +5 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Ten partnerships are on record, tiered core, key and supporting.

• Ottimo PharmacoreStrategic or Co-development Partner · 18 May 2026Expanded antibody manufacturing agreement building on an initial contract from June 2025. LOTTE Biologics produces the active pharmaceutical ingredient for Ottimo Pharma's biparatopic antibody OTP-01 (Jankistomig) targeting PD-1/VEGFR2 at its Syracuse Bio Campus in New York. The expanded partnership includes commercial process development and characterization activities, representing deeper integration into Ottimo Pharma's drug development pipeline from clinical through commercialization stages.
• Japan-Based Global Pharmaceutical CompanycoreStrategic or Co-development Partner · 6 April 2026Contract development and manufacturing agreement with a Japan-based global pharmaceutical company for biologics development and manufacturing. This partnership represents a step toward building a strategic collaboration framework and is expected to serve as a meaningful starting point for deeper collaboration in the Japanese market and globally.
• AsimovkeyTechnology or Integration · 9 March 2026Partnership for end-to-end cell line development services that reduce drug substance timelines to approximately 8.5 months. LOTTE Biologics collaborates with Asimov to provide integrated cell line development combined with its manufacturing capabilities, enabling faster path from gene to IND. Joint presentations are conducted at industry events (e.g., BIO USA 2026) to promote collaborative acceleration strategies.
• Rakuten MedicalcoreStrategic or Co-development Partner · 13 January 2026Master Service Agreement for GMP-compliant manufacturing of Rakuten Medical's photoimmunotherapy products at LOTTE Biologics' Syracuse facility. LOTTE Biologics manufactures monoclonal antibody intermediates and conjugates for Rakuten Medical's Alluminox platform-based therapy (ASP-1929/Akalux), supporting global Phase 3 clinical trials and future commercialization. The agreement was signed at the J.P. Morgan Healthcare Conference in San Francisco.
• Kanaph TherapeuticskeyTechnology or Integration · 12 December 2025Collaboration on next-generation ADC linker technology. LOTTE Biologics co-developed the SoluFlex Link™ hydrophilic linker platform with Kanaph Therapeutics, which holds core ADC linker technology. The companies conduct joint research on SoluFlex Link™, with results presented at AACR 2026 demonstrating platform benefits for ADC stability and efficacy. LOTTE Biologics also holds a strategic investment stake in Kanaph Therapeutics.
• SK pharmtecokeyStrategic or Co-development Partner · 29 October 2025Strategic partnership to strengthen global ADC CDMO capabilities. The collaboration aims to enhance both companies' positions in the ADC contract development and manufacturing market through combined expertise and global reach.
• ExcellGenesupportingTechnology or Integration · 20 January 2025Strategic partner for cell line development services, along with two undisclosed partners. ExcellGene provides transfection, pool generation, clone expansion, RCB generation, and MCB/WCB generation capabilities as part of LOTTE Biologics' cell line development ecosystem.
• Axcelead Drug Discovery PartnerssupportingTechnology or IntegrationADC technology partner listed on LOTTE Biologics' ADC partnerships page. Contributes to the company's strategic partnerships for ADC platform technologies alongside Kanaph Therapeutics, PinotBio, and SK pharmteco.
• PinotBiosupportingTechnology or IntegrationADC technology partner listed on LOTTE Biologics' ADC partnerships page, contributing to the strategic network of ADC technology collaborations.
• Global Drug Product Supplier (Undisclosed)supportingStrategic or Co-development PartnerStrategic partner for drug product (fill-finish) services, referenced as a key element of LOTTE Biologics' one-stop service offering from drug substance through clinical fill and finish.

Scale indicators9 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Samsung Biologics: Korea-based biologics CDMO operating the world's largest single-site manufacturing capacity. Directly comparable as a Korean-headquartered biologics CDMO serving global pharma with mAb and ADC services, though at materially larger scale.
• SK pharmteco: Global CDMO and already a strategic partner of Lotte Biologics for ADC services. Directly comparable as a CDMO offering small-molecule API and biologics manufacturing with growing ADC capabilities, and a direct ally/competitor in the same Korean ecosystem.
• Catalent: Global CDMO with biologics and ADC capabilities. Directly comparable in biologics and ADC services and large-pharma customer base, recently acquired by Novo Holdings — making it both a competitor and a strategic reference point for integrated biologics CDMO scale.
• AGC Biologics: Global CDMO offering mammalian-based biologics manufacturing and process development. Directly comparable in mAb CDMO services and biotech-to-commercial scale offerings, and similar mid-tier positioning relative to top global CDMOs.
• FUJIFILM Diosynth Biotechnologies: Global biologics CDMO with large-scale mammalian and microbial capacity. Directly comparable in end-to-end CDO/CMO services, regulatory maturity, and pursuit of large pharma commercial supply contracts.

Broad incumbents

• Celltrion: Korea-based biopharmaceutical company with biosimilars manufacturing and expanding CDMO services. Overlaps with Lotte Biologics in biologics manufacturing capability and Korean CDMO customer base, but Celltrion is also a product developer with its own biosimilar portfolio.
• WuXi Biologics: Global biologics CDMO leader based in China. Directly comparable in service offering (mAb, ADC, integrated CDO/CMO) and target customers, and is the principal beneficiary that US Biosecure Act may displace — creating share-shift opportunity for Lotte Biologics.
• Lonza Group: Switzerland-based global CDMO leader offering mammalian and microbial biologics, cell and gene therapy, and integrated services. Comparable in full-spectrum biologics CDMO capabilities and global pharma customer base, though far more diversified across modalities.
• Thermo Fisher Scientific (Patheon): Diversified life sciences and pharma services conglomerate whose Patheon CDMO business offers biologics and drug product services. Comparable in serving large global pharma with integrated CDMO offerings, though biologics is one of many segments within a much larger tools and services portfolio.

Emerging players

• Cytovance Biologics: US-based biologics CDMO offering mammalian and microbial contract manufacturing. Comparable in mAb CDMO services targeting clinical-stage biotech, though at smaller scale and narrower service offering than Lotte Biologics' dual-site network.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCydSCsDNUqYvPj4tSxc4aig
• LinkedInlinkedin.com/company/lotte-biologics

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments2 records

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about LOTTE Biologics