Scale-up for Virus Safety

Step 5

As you progress through clinical trials, the scale of your operation moves from bench top to pilot plant to full-scale production.

Navigating successfully from each phase to the next requires careful planning; scale-up studies are a key component to ensuring that your production process can grow along with the volume of material being produced.

Key points for consideration in your scale-up studies include:

• How will my operating parameters need to change as I move through each phase of clinical trials?
  
  
  • Will my evolving process continue to fit my physical plant?
  • What sanitization method will be most effective at each phase?
  • What pressure constraints might I encounter and how will I deal with each possibility?
  • Should I choose a disposable system or stay with a traditional stainless steel system?
    
    
• How will my process have to change to accommodate larger production volumes?
• What experiments should I be conducting to determine critical parameters and quickly identify potential issues?

Merck  can guide you as the scale of your manufacturing process grows. Our expert scientists and engineers are available to work with you, in your lab or ours, to identify solutions and to avoid potential problems before they occur.

Contact the Viresolve® Team to find out how.