42 BioProcess International Industry yearbook 2011–2012 advertorial

Selecting a CMo is critical to biotech biologic drug development. a key factor for selecting a CMo is 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. •

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.

CMO Selection CriteriaOutsourcing GMP Biologicals

Figure 1: Eurogentec’s project experience: 80 GMP processes developed; project development experience by project type as a CMO selection metric

Protein inE. coli

Protein inYeast

ProteinConjugate

PlasmidDNA

BSL2Microbe

34

30

24

20

16

12

8

4

0

Figure 3: GMP success rate (%) as a CMO selection metric

2006 2007 2008 2009 2010

100

90

80

70

60

50

40

30

20

10

0

Figure 2: Number of GMP site audits per year (1994–June 2011) as a CMO selection metric

9

8

7

6

5

4

3

2

1

19941995

19961997

19982000

20111999

20012002

20032004

20052006

20072008

20092010

1

0

2

4

2

0

2

8

5

4 4 4

6

3

5 5

3 3

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