Development
Manufacturing
Overview
Process and Analytical Development
DS Manufacturing
DP Manufacturing
Quality Control
Analytical Services
Capabilities
State-of-the-art Instruments
CRO Featured Services
Case Studies
Global CMC Submission
Services for Regulatory CMC Strategy
Services for FDA On-site Inspection
Services for cGMP Compliance
Quality System
Discovery Services, Global BD/ Marketing
400㎡
Cell Line Development, Upstream Process Development, Downstream Process Development, Formulation Development, Analytical services, Regulatory Affairs, and Corporate Headquarters
2-20L
4,500㎡
Pilot production for Pre-clinical, Phase I & II clinical trials, QC for Pilot Production
GMP : 1×500L, 2×200L
Non-GMP:2×200L
10,000㎡
Phase III & Commercial Production
DS manufacturing: 3 x 2,000L (single use), 3 x 5,000L (stainless steel)
Fill/finish: 1 x 14.5 m2 lyophilizer
66,000㎡
ADC design, Materials production & leads screening, ADC process development, ADC analytical services
1.5 ~ 400mL centrifuge tube,
0.5~20L glass reactor,
1,800㎡
Pilot production for Pre-clinical、Phase I & II clinical trials,
Phase III & commercial production,
ADC pilot & commercial production:
2 × 50L LDPE reactor,
2 × 200L LDPE reactor,
1-100L glass reactor,
Fill/finish:
1 x 5 ㎡ lyophilizer,
1 x 20 ㎡ lyophilizer,
6,400㎡