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Manufacturing Site

SYRACUSE, NY

As of 13 May 2022, LOTTE and Bristol Myers Squibb (hereafter "BMS") entered into a definitive agreement providing for the acquisition of the BMS manufacturing facility in Syracuse, NY.
The acquisition is subject to regulatory review and other customary closing conditions and is expected to be closed in 2022.
The Syracuse site has 35,000L Drug Substance manufacturing, storage, and quality control capabilities.
Manufacturing Site

Manufacturing Services

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Biological Drug Substance Manufacturing

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

* Upon obtaining all necessary regulatory approvals and completing the transaction.

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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)
Harvest
Centrifugation system
Downstream Process
Two independent purification suites
Chromatography System (Protein A, IEX/CEX)
Ultrafiltration/Diafiltration
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 will offer development service capabilities across the product life cycle, including product launches, scale-down process verification, and technology transfers (Upon obtaining all necessary regulatory approvals and completing the transaction).

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
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Analytical Testing Services

LOTTE BIOLOGICS will offer quality control testing services including analytical tech transfer, in-process testing, finished product testing, and stability testing (Upon obtaining all necessary regulatory approvals and consummating the contemplated transaction on the site acquisition).

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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

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