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Inspired by Science
- About US
- LOTTE BIOLOGICS is a biological CDMO(Contract Development Manufacturing Organization) company that provides a high level of manufacturing services from clinical to commercial products.
- Our Credo
- Our highest priority is to advance the quality of health of our end customers, our patients. By improving the health of the users of our products, we improve lives on a global scale and contribute to making a positive impact on the world.
- CMO Manufacturing Plant
- East Syracuse, NY, US
- 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. As of today, the facility received multiple product approvals from more than 60 different global regulatory bodies including FDA, EMA, PMDA, and MFDS.
- Biologics Manufacturing
- cGMP manufacturing services for clinical and commercial supply of biologics drug substance.
- Process Development
- Process development services including product launches, scale-down process verification and technology transfer.
- Analytical Testing
- Quality control services including analytical tech transfer, in-process testing, finished product testing, and stability testing.
- 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.