CMO Selection Criteria

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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.







Process Development Strategies

  • FastTrack — quick to clinic
  • OptiTrack — robustness built in.

 

About the Author

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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