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Bio B2BEirGenix, Inc. 〉CMC / CDMO (Contract Development and Manufacturing Organization)

CMC / CDMO (Contract Development and Manufacturing Organization)

EirGenix provides technical services and integral solutions that you can rely on. Core capabilities include cell line engineering, process development, analytical testing and cGMP manufacturing of biopharmaceuticals.

Mammalian system
- Monoclonal antibodies (novel and biosimilar mAbs)
- Fc-fusion proteins

Microbial system
- (Pegylated) Recombinant proteins
- Plasmid DNA
- Protein vaccine
- Biosimilars / Biobetters

Cell Line Engineering
- CHO & E. coli platforms (others such as NS0, PER. C6, HEK 293, hybridoma, pichia)
- From DNA construction to protein expression
- Highly productive stable cell line
- Medium screening by DoE (serum free /animal-free, chemical-defined)
- Research cell bank (RCB) production

Process Development
- Stand-alone and cGMP-enabling R&D Service
- Efficient phase-appropriate technology transfer
- Process scaling-up, fine-tune, optimization and troubleshooting
- Scale-down model development and process characterization by QbD
- Ensuring product productivity, product quality and cost effective process

Analytical Science
- Developing, qualifying, validating product specific analytical methods (AMD, AMQ, AMV)
-In-process, release, and stability testing
-Protein characterization
-Product quality analysis
-Quality risk management (e.g. functional relationships linking CMA / CPP to CQA)

cGMP Manufacturing
- Master cell bank (MCB) and working cell bank (WCB) production and storage
- Equipment qualification and process validation with risk assessment
- Regulatory compliant production of drug substance from clinical to commercial stages
- CMC documentation in CTD format support
- Continuous process verification and improvement
Service procedure
Initial Contact -> Sign CDA -> Clients fill in CMO/CDMO Request Form -> Eirgenix provides quotation with timeline -> Sign Contract
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