Entries by Thomas Gabrielczyk

Transition to industrial-scale AAV manufacturing

The switch from lab-scale to industrial-scale AAV production requires deep ­hands-on expertise in various technological solutions, their limitations, and their ­suitability for GMP large-scale manufacturing. Direct application of lab-scale process leads to expensive ­AAV-based products and unnecessarily laborious industrial processes. The complexity and growing demands for controllable critical quality attributes (CQAs), create a challenging blend.

High value biopharma process development

Biomanufacturing?Implementing high-quality process development that considers GMP manufacturing from the start is critical to reducing costs and timeline disruptions associated with raw material supply chain insecurity, adhering to regulatory compliance, and avoiding process re-design at a later stage.