Production
One-Stop Services
Celltrion provides one-stop services for the entire biopharmaceutical business process, from the development of initial substances to clinical trials, approval and production based on our world-class production facilities and quality management systems that are cGMP approved by the FDA.
Reliable Quality of Service
- Development Biopharmaceutical development capabilities accumulated from antibody biosimilar and novel therapeutics development
- Clinical Trials Successful clinical trial experiences ranging from small to large global trials
- Approval Acquired sales approval of various biopharmaceuticals from global regulatory agencies including the US FDA and Europe EMA
- Production Production facilities capable of responding to a variety of production scales from non-clinical to commercial production
Entering into Mutually Beneficial Partnerships
Through CDMO services, Celltrion provides professional capabilities in development, production, clinical operations and approval, and helps partners quickly develop new drug candidates by sharing development costs. Our partner companies can quickly develop new drug candidates based on Celltrion's capabilities, and Celltrion can selectively secure preferential rights to license-in candidate molecules, enabling mutual growth for both companies.
CDMO Process
- Screening of new
drug candidates - Development of
cell lines - Cell culture and
purification
process
development - Analysis method
development and
quality verification - Formulation
development - Clinical/non-
clinical material
production - Planning of clinical
trial - Preparation of
approval
documents
package - Commercial production
CDMO Process
- Screening of new
drug candidates - Development of
cell lines - Cell culture and
purification
process
development - Analysis method
development and
quality verification - Formulation
development - Clinical/non-
clinical material
production - Planning of clinical
trial - Preparation of
approval
documents
package - Commercial production
CDMO Brochure
CDMO.bd@celltrion.com