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We offer:
- Full scale biological manufacturing from initial concept
to commercial product
- pAVEway™
Process technology for expression optimization
- Master and Working Cell
Bank manufacturing capabilities
- Expression through a wide range of microbial and mammalian
cell systems with particular strengths in yeasts, Escherichia
coli, baculovirus and CHO
- Formulation Development
- Comprehensive in-house analytical
capabilities
- Commercial product Qualified Person release
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Some facts and figures:
- Experience with >180 complex proteins
- Commercial manufacture of 5 licensed products
- 100L to 5000L manufacturing across a broad range of scales
- Flexible operations aligned to needs
- Over 250 process development scientists and engineers
- Regulatory approvals by FDA (CBER and CDER), EMA, Health Canada, MHRA, ANVISA and certified by JMHLW
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