EirGenix is Taiwan’s largest contract development and manufacturing organization (CDMO) specialising in both mammalian and microbial-derived biologics. The company provides comprehensive, one-stop services that cover the entire spectrum from pre-clinical development to commercial manufacturing. EirGenix boasts extensive experience with a range of biologics, including monoclonal and bi/poly-specific antibodies, recombinant proteins, antibody-drug conjugates (ADCs), and plasmid DNAs. It is noteworthy that EirGenix is the only CDMO in Taiwan with biomanufacturing facilities that have received approval from multiple international regulatory authorities, including the US FDA, Japan PMDA, Australia TGA, and EU EMA.

Types of Drugs Manufactured:

Biologics

CDMO Services:

Drug Substance Manufacturing (API);Research & Development;Regulatory Services;Analytical Development;Process & Forumulation Development

Therapeutic Area:

Cardiovascular;Central Nervous System;Gastrointestinal and Metabolism;Hematology;Immunology;Infectious Disease;Oncology;Ophthalmology;Platform Technologies

Facilities Location:

East Asia

Regulatory Approvals for facilities:

USA – FDA;Europe – EMA or constituent countries;GMP;Japan – MHLW;Australia – TGA

Manufacturing Technologies:

Lyophilized amps/vials;Sterile Vials

Current Capacity:

from R&D scale to commercial
Stainleass Steel & SUB (12*2000L)
Microbial & Mammalian Expression System