Manufacturing Site
SYRACUSE, NY
- 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 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)
- 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 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
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.
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.