- Alvotech and LOTTE Biologics have entered a long-term strategic manufacturing partnership under which LOTTE Biologics will manufacture drug substance for multiple antibody biosimilar products at its Syracuse, New York facility for global supply.
- The Syracuse facility has 40,000 liters of bioreactor capacity for biologics manufacturing, with on-site process development and quality control capabilities.
Alvotech and LOTTE Biologics have announced a long-term strategic manufacturing partnership to support global supply of multiple antibody biosimilar products. Under the agreement, LOTTE Biologics will manufacture drug substance at its Syracuse, New York facility, with the potential for the collaboration to expand over time.
The Syracuse facility has 40,000 liters of bioreactor capacity for biologics manufacturing and includes on-site process development and quality control capabilities. The site has an established track record in commercial biologics manufacturing and recently completed an unannounced FDA inspection with zero observations, according to the companies.
The agreement expands Alvotech’s U.S.-based manufacturing footprint and adds capacity to its global supply network. The additional manufacturing capacity will complement Alvotech’s existing manufacturing partnerships and in-house development and manufacturing capabilities as the company expands its biosimilar portfolio and prepares for future launches.
“Alvotech’s expertise in biosimilar development, combined with LOTTE Biologics’ manufacturing capabilities, creates a strong foundation for this collaboration. We look forward to strategically supporting Alvotech’s growing portfolio and the reliable supply of high-quality, more affordable biologic medicines to patients worldwide.”
James Park, CEO of LOTTE Biologics
Commercial supply under the partnership will be subject to successful technology transfer, manufacturing qualification and applicable regulatory approvals. LOTTE Biologics’ Syracuse operations and Songdo Bio Campus are expected to provide dual-site manufacturing support as the partnership develops.
