Manufacturing Site


The Syracuse site has 35,000L Drug Substance manufacturing, storage, and quality control capabilities. The facility is fully GMP operational with clinical and commercial capabilities. The facility has received more than 60 approvals from global regulatory bodies including FDA, EMA, PMDA, and MFDS.
Manufacturing Site

Manufacturing Services

services services

Biological Drug Substance Manufacturing

LOTTE BIOLOGICS offers cGMP manufacturing services for clinical and commercial supply of biologics Drug Substance. We operate three independent inoculation suites and two downstream suites to accommodate multi-product operations. A highly talented and experienced team delivers quality products on time.

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    Cell Culture Capacity35,000 Liters

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    Three InoculationSuites

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    Two PurificationSuites

Cell Banking & Inoculum
Liquid nitrogen tank
Biosafety cabinet
Wave Bioreactors
Cell Culture
Three independent inoculation suites
Seven 5kL production bioreactors (total 35kL)
Centrifugation system
Downstream Process
Two independent purification suites
Chromatography System (Protein A, IEX/CEX)
Virus Filtration System
Cryogenic Storage of Drug Substance
-20, -60, -70℃ Freezers
2-8 ℃ Cold rooms
Five -40℃ walk-in freezers
Freeze/Thawing Equipment

Development Services

LOTTE BIOLOGICS offers development service capabilities across the product life cycle, including product launches, scale-down process verification, and technology transfers.

Process Development can perform the following

Product stewardship for the products manufactured at the site
Provide full support on technical strategic leadership and scientific expertise
Drive technical support and life-cycle management from development through commercial products
Execute facility fit and technology transfers
CMC strategy and authorship

List of Current Equipment for Process and Analytical Development at the Syracuse site

Lab-scale bioreactor
Media preparation mixers
Wave bioreactors
AKTA purifiers and TFF systems
HPLCs, TOC Analyzers, ELISA, UV/Vis spectrophotometers
Biosafety Cabinets

Analytical Testing Services

LOTTE BIOLOGICS offers quality control testing services including analytical tech transfer, in-process testing, finished product testing, and stability testing.


Our Analytical Services (QC) Team can
perform the following tests

Incoming raw materials testing
In-Process testing (pH, purity, protein concentration, bioactivity etcs. as appropriate)
Drug Substance release testing
UV Absorbance
HPLC/UPLC, GS (Gas Chromatography)
Microbial testing (Endotoxin, Bioburden)
Microbial Identification
TOC (Total Organic Carbon)
SDS-PAGE, Immuno-blotting (Western blots)
Impurity Analysis (ICP-MS)
Cell-based potency
Stability testing
ELISA (Enzyme-Linked Immunosorbent Assay)
MODA-EM® Paperless QC Microbiology


Quality is our first priority as a CMO company.
With robust quality systems and proven regulatory track records at our GMP facility, we supply the highest quality products to our customers.

Qualit management system
Quality and Regulatory Compliance

Quality and regulatory compliance is our priority at LOTTE BIOLOGICS.
LOTTE BIOLOGICS is committed to providing the highest quality products to our customers.