EirGenix, Inc.
Biopharmaceutical CDMO and developer focused on monoclonal antibody biosimilars, antibody-drug conjugates, vaccine carrier proteins and related biologics. Operates cGMP mammalian and microbial facilities in Taiwan with single-use bioreactor capacity to support preclinical through commercial manufacture, analytical testing and regulatory filings in major markets.
Industries
Nr. of Employees
medium (51-250)
Patents
Products
EG12014 (trastuzumab biosimilar)
Monoclonal antibody biosimilar candidate targeting HER2 for oncology indications; progressed through Phase III and regulatory filing stages.
EG1206A (pertuzumab biosimilar candidate)
Second-generation HER2-targeted monoclonal antibody biosimilar candidate in clinical development.
EG12021 (anti-angiogenesis biosimilar candidate)
Biosimilar candidate targeting angiogenesis pathways for solid tumor indications (preclinical).
EG74032 (CRM197 carrier protein)
CRM197 carrier protein supplied in GMP and R&D grades for conjugate vaccine development and related applications.
COVID-19 antigen rapid test (lateral flow)
Lateral-flow antigen diagnostic test designed for rapid detection with results reported in approximately 10 minutes.
EG12014 (trastuzumab biosimilar)
Monoclonal antibody biosimilar candidate targeting HER2 for oncology indications; progressed through Phase III and regulatory filing stages.
EG1206A (pertuzumab biosimilar candidate)
Second-generation HER2-targeted monoclonal antibody biosimilar candidate in clinical development.
EG12021 (anti-angiogenesis biosimilar candidate)
Biosimilar candidate targeting angiogenesis pathways for solid tumor indications (preclinical).
EG74032 (CRM197 carrier protein)
CRM197 carrier protein supplied in GMP and R&D grades for conjugate vaccine development and related applications.
COVID-19 antigen rapid test (lateral flow)
Lateral-flow antigen diagnostic test designed for rapid detection with results reported in approximately 10 minutes.
Services
Integrated services from cell line development through process development, analytical/QC and cGMP manufacturing for mammalian and microbial biologics.
Generation and selection of stable producer cell lines for biologic products to support upstream process and manufacturing.
Upstream optimization and downstream purification/process scale-up including chromatography and filtration strategies.
Analytical method development, release testing and QC to support comparability, stability and regulatory filings.
Clinical and commercial cGMP production lines for mammalian cell culture and microbial fermentation with segregated cleanrooms and fill-finish capability.
CMC-focused services for ADCs including conjugation process development and integration with analytical and manufacturing workflows.
Integrated services from cell line development through process development, analytical/QC and cGMP manufacturing for mammalian and microbial biologics.
Generation and selection of stable producer cell lines for biologic products to support upstream process and manufacturing.
Upstream optimization and downstream purification/process scale-up including chromatography and filtration strategies.
Analytical method development, release testing and QC to support comparability, stability and regulatory filings.
Clinical and commercial cGMP production lines for mammalian cell culture and microbial fermentation with segregated cleanrooms and fill-finish capability.
CMC-focused services for ADCs including conjugation process development and integration with analytical and manufacturing workflows.
Expertise Areas
- Contract development and manufacturing (CDMO)
- Monoclonal antibody biosimilar development
- Large-scale mammalian cell culture manufacturing
- Microbial fermentation and downstream processing
Key Technologies
- Single-use bioreactor systems (50 L–2,000 L)
- Tangential flow filtration (TFF)
- Column chromatography (multiple column sizes)
- Depth filtration
News & Updates
Attendance and exhibition at international conferences including BIO Convention, CPhI and BIOASIA (listed events across 2022–2024).
European Commission granted marketing authorization for the company's trastuzumab biosimilar for HER2-positive breast and gastric cancer indications; product also received national approval and pricing steps in Taiwan.
Facility approvals and accreditations reported, including approvals from Japan PMDA and stated approval/recognition from the US FDA for facilities.
Reported favorable scientific consultation outcomes with regulators regarding waiver of Phase III clinical trials for a HER2-targeted biosimilar candidate, enabling expedited regulatory submissions.
Commercial licensing agreements executed for biosimilar assets as part of international commercialization strategies.
Multiple industry awards and recognitions listed, including regional bioprocessing excellence and CMO awards across 2017–2020.
Attendance and exhibition at international conferences including BIO Convention, CPhI and BIOASIA (listed events across 2022–2024).
European Commission granted marketing authorization for the company's trastuzumab biosimilar for HER2-positive breast and gastric cancer indications; product also received national approval and pricing steps in Taiwan.
Facility approvals and accreditations reported, including approvals from Japan PMDA and stated approval/recognition from the US FDA for facilities.
Reported favorable scientific consultation outcomes with regulators regarding waiver of Phase III clinical trials for a HER2-targeted biosimilar candidate, enabling expedited regulatory submissions.
Commercial licensing agreements executed for biosimilar assets as part of international commercialization strategies.
Multiple industry awards and recognitions listed, including regional bioprocessing excellence and CMO awards across 2017–2020.