Highly skilled staff in all areas required to develop and manufacture high quality and regulatory compliant biologics
Comprehensive Analytical Services
Cell Line Development
Cell Culture (Upstream) Process Development
Purification (Downstream) Process Development
Formulation Development
Drug Product Development
HPLC
CE
Compendial
Mass Spectrometry
ELISA
Binding Kinetics
(BLI/Octet)
Cell-Based Assays
Residual DNA (qPCR)
GMP Compliance (21 CFR Parts 210/211/11)
Fully independent Quality department (QA & QC)
Document Control
Training
CMC & Clinical Regulatory
Upstream Clean Room(ISO 8)
Downstream Clean Room (ISO 7)
200L Bioreactor W/V
Perfusion Process Capable
Single-Use Tech Throughout
Bulk Drug Substance Fill
Supplier & Inventory Management
Clinical Research Organization (CRO)Vetting and Selection
CRO Bidding
Contract Negotiation
Vendor Management