- 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.
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.
Cell Culture Capacity35,000 Liters
- 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
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
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).
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 of our GMP facility, we ensures to supply 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 provide highest quality products to our customers.