our Experience / Skills

Biotechnology Consulting

who we are

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Fed-batch CHO, perfusion
Technology Transfer (donating and receiving site)
Manufacturing support of largest CHO drug substance producer in Roche/Genentech network
GMP - discrepancy, change control, documentation, training
Risk assessment and management
Process characterization and validation - protocol, execution, and report
Microbial control optimization
Regulatory observation reponse and inspection support
Implementation of analytical equipment
Early and late stage process development