CDMO

CDMO Business

Celltrion’s CDMO services is dedicated to meeting the unique needs of our partners, offering comprehensive solutions across the entire product life cycle. From initial development and process optimization to extensive manufacturing and regulatory guidance, our world-class facilities and highly skilled experts are primed to address even the most intricate challenges. Elevate your biopharmaceutical endeavors with our all-encompassing CDMO services, providing holistic support for clinical trial materials, commercial production, and regulatory compliance.

Multiples Scale & Multiple Capacities

Celltrion offers a wide range of production options from 1,000L to 15,000L to meet both clinical and commercial requirements. With a specialized focus on Plant 3, we excel in 1,500L, 5,500L to 7,500L production, ensuring diverse market satisfaction.

A Reliable Partner

Celltrion is a trusted partner with a proven track record, boasting 2,100+ successful cGMP DS batches and a 98.5% batch success rate. With over 400 regulatory approvals in 90+ countries, including FDA, EMA and more, along with 54 successful inspections, we deliver reliability and expertise in CDMO services.

Celltrion Pharm PFS CMO Services

Celltrion Pharm offers competitive pricing to local and international pharmaceutical companies looking for PFS filling, packaging and auto injector assembly capacities. It offers easy access to the Asia-Pacific region and other International locations.

Facility & Equipment

Facilities approved by FDA & EMAEMA-approved commercial manufacturing facility for injectablesHigh-performance equipment showcasing the latest pharmaceutical technologyOn-site microbial laboratory and chemistry testing

Flexible Commercial CMO Services

Option 1

Aseptic processing (formulation → filling → inspection)After filling, external shipment or assembly process is available

Option 2

Option 1 + assembly and packaging for PFS aseptic processing → PFS assembly → cartoning → track & trace → case packing

Option 3

Option 1 + assembly and packaging for AI aseptic processing → AI assembly & labeling → cartoning → track & trace → case packing

Option 4

AI assembly & labeling → cartoning → track & trace → case packingSemi auto AI assembly and labeling is also possible