Development Services
LOTTE BIOLOGICS offers development service capabilities across the product life cycle,
including product launches, scale-down process verification, and technology transfers.
Cell Line Development
LOTTE BIOLOGICS offers the development of cell lines through partnerships with various CDO partners.
- Transfection
- • Transfection of mammalian expression vectors in host cell line
- Pool Generation & Isolation
- • Stable pool generation
- • Gentle single cell sorting with outstanding viability
- Clone Expansion & Ranking
- • Expansion of single cell clones
- • Ranking of clones by productivity
- RCB Generation
- • RCB generation from top performing clones
MS&T
- Product stewardship for the products manufactured at the site and support for product introductions that utilize new processes through to validation
- 24/7 day-to-day technical strategic leadership, troubleshooting and scientific expertise
- Technical support and life-cycle management from development through to commercial products
- Resolution of process deviations as well as investigations and implementation of Corrective Action/Preventative Action (CAPA)
- Development and support for scale-up studies from laboratory-scale to manufacturing scale
- Swift and seamless technology transfer, enabling rapid product commercialization and ensuring uninterrupted product supply
- Experience in CMC strategy and authorship, including specialization in both the internal development and external transfer of processes and methods to CMOs