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Bio B2BEirGenix, Inc. 〉Pilot scale up development and cGMP manufacturing of biopharamaceutical drug substance (DS)

Pilot scale up development and cGMP manufacturing of biopharamaceutical drug substance (DS)


EirGenix is a CDMO to perform high quality and cost-effective services supporting our clients in development, analytical testing, and GMP manufacturing of biopharmaceuticals from pre-clinical to commercial manufacturing.


Process Development Capacity
- Flow sorter for cell pool titer enrichment
- Automated photo-documentation for monoclonal formation
- Micro bioreactor system for cell line development and process optimization
- 2L/5L bench top bioreactors
- 2L/20L fermentors
- 20L and 100L stainless steel bioreactors
- 50L single use bioreactor
- Disc centrifuge and continuous centrifuge
- Homogenizer and refolding tank
- Liquid chromatography systems
- MF, UF, UF/DF TFF system
- Purity analysis using HPLC or UPLC
- Preformulation study
- Lyophilizer
- Stability chamber
- Programmable controlled freezing and thawing system

Microbial Manufacturing Capacity
E. Coli/Pichia soluble protein, inclusion body, plasmid DNA
Upstream
- 30/150L fermenter
Downstream
- Microfiltration/Centrifuge
- Microfiltration/Ultrafiltration
- Disk/Floor Centrifuge
- Homogenizer
- Refolding tank
- Chromatography skid and column
Commercial Plant
- Currently under construction
- 500L or 1000L fermentor available

Mammalian Manufacturing Capacity
CHO (e.g. Anti-IL 20, Anti-HSV, Anti-TNFa), NS0, PER.C6
Two Upstream Suites
- 50/200/1000L Single Use Bioreactor (SUB) System
- 20/100/500L Stainless Bioreactor
Downstream
- Depth filtration
- Ultrafiltration unit
- Chromatography skids and columns
Central Control System
Commercial Plant
- Currently under construction
- Several 2000L available

Regulatory Experience
- US FDA DMF 19164
- EU EMA
- Japan PMDA
- Taiwan FDA
 
Service procedure
Initial Contact -> Sign CDA -> Clients fill in CMO/CDMO Request Form -> Eirgenix provides quotation with timeline -> Sign Contract
 
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