Main Services:
BORA is the largest CDMO in Taiwan with 7 cGMP sites and comprehensive biologics & small molecule CMC development and commercial manufacturing capabilities.
BORA has strategically located manufacturing facilities in Taiwan, USA, and Canada, all with cGMP Licenses and many of which have been inspected by various Global Regulatory Agencies and with 0 major quality observations across our network. BORA’s areas of expertise specifically tailored for biologics are:
• CMC Program Design from DNA to IND & Risk Assessments/Mitigation • High-Titer Proprietary Cell Line Development with No Licensing Fees* • Process Development & Optimization Platform • Analytical Method Development/Qualification/Validation, All Inclusive • Full Formulation Development, including High Concentrations • cGMP Manufacturing for US, EU, and Global Clinical Trials • In-Depth Protein Characterization for Complex Molecules with 45+ Assays in-house
BORA’s experience across multiple protein classes cover: • Monoclonal Antibodies • Fc Fusion Proteins • Bi-Specific/Tri-Specific Antibodies • Enzymes and other Recombinant Proteins • Antibodies used in ADC construction • Complex Protein Conjugates
*With full IND package
Business Interests
BORA’s team is here to discuss how we can become a trusted partner to help bring your breakthrough biologics successfully to market utilizing our platform & unique developer experience.
▪ Biologics CDMO: Establishing Cell Line, Process Optimization, Analytical/Formulation Development, Tox Study Material, cGMP Manufacturing, Global Quality, Stability Programs, Clinical Support
Contact Info
Steven Huang
Director of Business Development
+886-3-658-3899
steven.huang@borabiologics.com