LOTTE Biologics provides end-to-end contract development and manufacturing organization (CDMO) services for biopharmaceuticals, including cGMP manufacturing and analytical testing, to ensure high-quality production of biological drug substances. The company addresses the need for reliable and scalable manufacturing solutions in the biopharmaceutical industry, supporting clients from development through to commercial supply.
Funding
Funding not disclosed
Founders
Product
Problem
Biopharmaceutical companies often face challenges in securing reliable and scalable manufacturing solutions for their biological drug substances, which can hinder development timelines and commercial supply. Ensuring high-quality production and adherence to stringent cGMP standards adds further complexity.
Solution
LOTTE Biologics provides comprehensive, end-to-end contract development and manufacturing organization (CDMO) services to biopharmaceutical companies. These services encompass development, clinical and commercial manufacturing, and analytical testing. LOTTE Biologics supports clients throughout the entire product lifecycle, from initial development and scale-up to cGMP manufacturing for clinical trials and commercial supply. The company's expertise includes process development, analytical tech transfer, and quality control testing, ensuring adherence to regulatory requirements and the delivery of high-quality biological drug substances.
Target Audience
LOTTE Biologics primarily serves biopharmaceutical companies requiring CDMO services for the development and manufacturing of biological drug substances.
Features
- cGMP manufacturing services for clinical and commercial supply of drug substance
- Development services including product launch support, scale-down process verification, and technology transfers
- Analytical testing services encompassing analytical tech transfer, in-process testing, finished product testing, and stability testing
- ADC conjugation services, combining monoclonal antibodies with small-molecule drugs using stable linkers
- Robust quality systems and proven regulatory track record