EirGenix has core capacity in R&D and manufacturing, producing biologics compliant with PIC/S GMP, and has 7 products undergoing development. EirGenix has two main business units:
1.Contract Development & Manufacturing Operation Unit:
EirGenix produces microbial and mammalian cell based biologics compliant with PIC/S GMP from cell line development to drug substance, and provides process development and quality control (QC) analysis for products.
Cell Line Development & Cell Banking Service:
Contract Development & Manufacturing Service:
Analytical Science & QC analysis Service:
Antibody Drug Conjugate (ADC) service: Partnering with Formosa Laboratories, Ltd.
2.Product Development & Operations Unit:
EirGenix currently has seven biologics undergoing development.
EG12014/EGI014 (Trastuzumab Biosimilar) treats HER2 gene variance cancer. It received approval from US FDA, Taiwan FDA, EMA...etc and began phase III clinical trial.
EG1206A (Pertuzumab Biosimilar) treats HER2 gene variance cancer.
EG13074 (New Formulation) treats HER2 gene variance cancer.
TSY0110(EG12043) (Antibody-Drug Conjugate) treats HER2 gene variance cancer.
EG12021 (Bevacizumab Biosimilar) inhibits cancer by anti-angiogenesis.
EG74032 (CRM197 Carrier Protein) can be used for vaccination.
EirGenix has core capacity in R&D and manufacturing, executing Contract Development & Manufacturing Services for clients producing microbial and mammalian cell based biologics compliant with PIC/S GMP regulation.
Cooperation projects and needs
1. Provide Cell Line Development, Manufacturing Process Development , and Analytical Service
2. Provide PIC/S GMP Manufacturing Service of biologics including recombinant protein, fusion protein, plasmid, monoclonal antibody, biosimilar etc.
3. Provide Analytical Science & QC analysis Service