Development
Manufacturing
Overview
DS Manufacturing
DP Manufacturing
Quality Control
Analytical Services
Capabilities
Major Instruments
CRO Featured Services
Successful Cases
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㎡