Outsourcing GMP Biologicals

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Selection of a CMO is critical to biologic drug development; and the primary selection criterion is experience. How do biotech companies measure experience? CMO experience can be measured in many ways — primary metrics include (1) total number of GMP processes developed by a CMO; (2) number of projects involving your strain; (3) number of projects involving your product type; (4) GMP production success rate; (5) total number of GMP lots produced; and (6) number of quality audits.”

Eurogentec’s biologics division is specialized in the manufacturing of biopharmaceuticals from microbial sources: bacteria, yeast, and biosafety level 2 (BSl-2) organisms. Eurogentec has manufactured according to GMP since 1994.






 

 

Host Cell Experience: Microbial Experts

 

Eurogentec has expertise with E. coli, P. pastoris, H. polymorpha, S. cerevisiae, and 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
  • GMP fermentation suites: 80 L, 150 L, 500 L fermenters
  • 2 GMP purification suites
  • 1 GMP sterile filtration suite

 

Process Development Strategies

 

  • FastTrack
  • OptiTrack
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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