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CMC Forum Press Releases
Outsourcing GMP Biologicals
Pascal Bolon
BioProcess International, Vol. 8, No. 7, July–August 2010, p. 44
 



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

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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Biopharmaceutical Production
Facility Design Strategies for Single-Use Technologies

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Wednesday, 29 February 2012
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Research Engineer
GE Healthcare Life Sciences

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* Benefits of facility design with respect to cost, risk, and flexibility

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