| Brief |
Our company, EirGenix, Inc., is a Contract Development and Manufacturing Organization (CDMO) specializing in biologics. We offer customizable, client-centric services to assist our customers to achieve their business goals. We can provide full-scope services from cell line development and process optimization, to small-scale and commercial mass production of both mammalian and microbial cell-based biologics. Our PIC/S GMP-compliant facilities are operated with utmost efficiency to ensure we deliver you both high-quality and cost effective services. We have extensive experience working with a variety of biological substances (mAb, r-proteins, fusion proteins, bispecific mAb and ADC and etc.). In the last 7 years, we have worked with clients all over the world, handling more than 70 biologics projects, both from early-stage and late-stage developments. We are also the first company in Taiwan to have a biomanufacturing facility approved by Japan's PMDA.
PRODUCTS & SERVICES:
1. Contract Development & Manufacturing Services
Cell Line Development & Cell Banking Service:
- From DNA to stable cell lines includes CHO cell (CHO-S and CHO-K1), E. Coli, and Pichia.
- MCB/ WCB/ EPC production
Process Development & PIC/S GMP Manufacturing:
- Development and optimization for upstream & downstream process
- Manufacture microbial (150L) and mammalian cell-(200L/500L/1000L/2000L/4000L) based biologics compliant with PIC/S GMP standard
QC Analysis Services:
- Provide analytical method development, qualification, and validation
- Analysis includes identification, quantification, purity, potency, impurity, safety…etc
Antibody Drug Conjugate (ADC) Service: partnering with Formosa Laboratories, Ltd.
Accelerated development and manufacturing services for COVID-19:
- mAb for treatment of COVID-19
- Antigens for COVID-19 vaccine development
- CRM197 carrier protein (enhanced delivery of conjugate vaccines) for COVID-19 vaccine development
2. Product Development:
7 Products in Development:
Trastuzumab Biosimilar (EG12014/EGI014) (Partnered with Sandoz)
Pertuzumab Biosimilar (EG1206A)
Trastuzumab New Formulation (EG13074) (Strategic alliance with Formosa Laboratories, Inc.)
Antibody-Drug Conjugate (TSY0110/EG12043)
Bevacizumab Biosimilar (EG12021)
CRM197 Carrier Protein (EG74032)
Biosimilar (EG62054)
3. COVID-19 Antigen Rapid Test (Vstrip) (Developed by AEP Alliance - AnTaimmu BioMed, EirGenix, and Panion & BF Biotech)
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