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
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