Biotechnology Consulting

our Experience / Skills

who we are

• Monoclonal Antibody: Fed-batch CHO, perfusion
• Cell Therapy
  
• Technology Transfer (transferring and receiving site)
• Manufacturing support of largest CHO drug substance producer in Roche/Genentech network
• Consulting with contract manufacturers, small and large companies
  
• GMP - discrepancy, change control, documentation, training​​
• Risk assessment and management
• Process characterization and validation - protocol, execution, and report
• Microbial control optimization
• Extractables and Leachables - risk assessment, management of testing, strategy
• ​Regulatory observation response and inspection support
• Implementation of analytical equipment
• Early and late stage process development​
  

Passionate about creating efficiency, optimizing Technical and business processes, and knowledge management