Late Stage Development
PolyPeptide approaches manufacturing with Quality by Design concepts that include risk based approaches. During Late Stage Development, the process is challenged to understand and define the ranges of critical and key parameters. The parameters are monitored on an on-going basis to ensure the process stays with in control and thereby ensuring a greater success rate of batches during commercial manufacturing. This create a manufacturing process that is robust and economical. A key part of the design of the late stage development focuses on obtaining the correct process for the commercial quantity requirements at a desired target price.