Workshop A

Examining the Viability of Process-Specific Analysis Replacing Control Banding to Avoid Over- Engineering & Maximize Cost-Effectiveness

Time: 8:30 am
day: Workshop A


Control banding has long been a critical element of process development for highly potent drugs. However, as potency increases and containment requirements increase, could a process-specific approach drive costs down and improve process safety?

Topics include:

  • Uncovering how the current banding structure can lead to overengineering
  • Assessing process-specific methods to determine the API’s handling level
  • Evaluating how to remain harmonized with CDMOs