About

EirGenix is the leading company in biologics development and GMP manufacturing and has solid experience in various biologics (mAb, bi-specific mAbs, r-proteins, COVID-19 Spike protein, fusion proteins, RNA, ADC, Viral Vector, etc.). As of now, we have successfully completed more than 70 biologics projects for clients all over the world. Moreover, we have signed global licensing collaborations with Sandoz for our Trastuzumab biosimilar (EG12014), which BLA has been submitted to the US FDA in December 2021. Among others, our services include: - Up to 12x2,000L SUB mammalian cGMP production capacity - Dual cell Line development & banking for mammalian and microbial systems - Upstream/Downstream process development - Analytical and QC - One-stop full service from DS to DP - US FDA inspected and the EIR report received - Japan PMDA and Taiwan FDA certified - Biosimilars pipeline available for licensing and or collaboration About EirGenix, Inc. EirGenix is a leading CDMO in biologics development and GMP manufacturing that has solid experience in various biologics (mAb, BsAbs, r-proteins, COVID-19 Spike protein, fusion proteins, ADC, pDNA, Viral Vector, etc.). We have completed > 70 biologics projects for clients all over the world. Moreover, we have signed global licensing collaborations with Sandoz for our Trastuzumab biosimilar (EG12014), which BLA was approved in the EU and waiting for US FDA approval. Among others, our services include: - One-stop full service from DS to DP CGMP Clinical and Commercial manufacturing of Microbial and Mammalian strains - Up to 12 x 2,000L mammalian capacity - Dual Cell Line Development & banking for mammalian and microbial systems - Upstream/Downstream process development - Analytical and QC - US FDA, Japan PMDA, Australia TGA, EU EMA, and Taiwan FDA inspected - Biosimilars pipeline available for licensing and or collaboration About EirGenix, Inc. EirGenix is a leading CDMO in biologics development and GMP manufacturing that has solid experience in various biologics (mAb, BsAbs, r-proteins, COVID-19 Spike protein, fusion proteins, ADC, pDNA, Viral Vector, etc.). We have completed > 70 biologics projects for clients all over the world. Moreover, we have signed global licensing collaborations with Sandoz for our Trastuzumab biosimilar (EG12014), which BLA was approved in the EU and waiting for US FDA approval. Among others, our services include: - One-stop full service from DS to DP CGMP Clinical and Commercial manufacturing of Microbial and Mammalian strains - Up to 12 x 2,000L mammalian capacity - Dual Cell Line Development & banking for mammalian and microbial systems - Upstream/Downstream process development - Analytical and QC - US FDA, Japan PMDA, Australia TGA, EU EMA, and Taiwan FDA inspected - Biosimilars pipeline available for licensing and or collaboration EirGenix is Taiwan’s leading biologics CDMO, providing end-to-end development and manufacturing solutions that meet FDA, PMDA, EMA, and TGA standards. Since 2012, we have successfully delivered 100+ projects across mammalian and microbial platforms, supporting global clients from early-stage development to commercialization. Our comprehensive services include cell line development, process and analytical development, and cGMP manufacturing for both clinical and commercial supply. With a robust 12 × 2,000L single-use bioreactor capacity and expanding microbial fermentation capabilities, we are equipped to handle large-scale production needs. Award-Winning Excellence Since 2017, EirGenix has been consistently recognized for excellence in biologics development and manufacturing, earning multiple prestigious industry awards that demonstrate our commitment to innovation and quality. Recent Awards (2023-2025): - Best ADC CDMO in Taiwan – Asia Pacific Biopharma Excellence Awards 2025 - Most Promising Monoclonal Antibodies Pipeline – Taiwan Biopharma Excellence Awards (TBEA) 2024 - National Science and Technology Drug R&D Award – Gold Medal (2023, Taiwan) (for EirGasun® 150mg) - BioProcessing Excellence Award – Greater China Region (2022) (IMAPAC Asia Biologics - Manufacturing Conference) Accelerate your biologics development with EirGenix. Visit us at BIO 2025 or contact us to explore tailored solutions for your next project.