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CMC Forum Press Releases

CMO Selection Criteria

Pascal Bolon
BioProcess International, Vol. 9, No. 7, August 2011, p. 42
 




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Selecting a CMOis critical to biotech biologic drug development. A key factor for selecting a CMOis experience. How do you measure experience? It can be measured in many ways, metrics include

  • Number of GMP processes developed by the CMO

  • Number of projects involving your strain

  • Number of projects involving your product type

  • GMP production success rate

  • Number of GMP lots produced.



Eurogentec's Biologics Division is specialized in the manufacturing of biopharmaceuticals from microbial sources such as bacteria, yeast, and biosafety level 2 organisms. Eurogentec manufactures in accordance with GMP since 1994.

Host Cell Experience — Microbial Experts

  • Escherichia coli

  • Pichia pastoris

  • Hansenula polymorpha

  • Saccharomyces cerevisiae

  • Numerous BSL-2 organisms.



Chemistry Experience — Conjugation Experts

  • Maleimide

  • Glutaraldehyde

  • Other chemistries available.



Product Family Experience

  • Recombinant proteins

  • Plasmid DNA

  • Protein–PEG conjugations

  • Protein–protein conjugations

  • Protein–peptide conjugations.



GMP Infrastructure

  • Multiproduct facility

  • Separate HVAC systems

  • Three GMP fermentation suites (80 L, 150 L, 500 L)

  • Two GMP purification suites

  • One GMP sterile filtration suite.




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Process Development Strategies

  • FastTrack — quick to clinic

  • OptiTrack — robustness built in.

Author Details
Dr. Pascal Bolon is biologics sales and marketing manager at Eurogentec SA, Rue du Bois Saint-Jean 5, 4102 Seraing, Belgium; 32-4-366-6116; biologics@eurogentec.com.

 
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