Biotechnology Consulting

Monoclonal antibody and cell therapy. Small-scale and at-scale. Assessment for extractables & leachables, mixing, process and solution hold, microbial control.

Our Services

Process Validation

On-site support, discrepancy resolution, change control, inspection support.

Manufacturing

Process scale-up. Information transfer (transferring and receiving site). Person-in-plant support.

Optimization

Technology Transfer

Process and operational improvement. Data analysis and management. Creation and maintenance of document templates.