The key to effective technical transfer is to clearly map out the transfer process and to carefully select and carry out good due diligence of CMO partners with experience in developing the drug dosage form you are looking to transfer. This means engaging with CMOs who can leverage pilot scale equipment as part of the qualification to find the optimum processes early in the development life cycle, iron out kinks and plan qualification activities. It is key to identify these process technologies early and once down selected to then minimise the level of change and added complexity as the development and scale up progresses. The client and CMO can learn the sensitivity and behavior of the process early and manage or avoid potential pitfalls.
Another critical consideration is robust formulation development. Scale up and process optimisation can improve the performance of a manufacturing process but only if there is a solid foundation and a robust formulation design in the first place. The client and CMO must also complete process qualification to verify that the transferred process is reproducible during industrial scale commercial manufacture. The key is to ensure that quality has been designed into the process and critical control process parameters and material attributes are identified that control the quality of the product during manufacture rather than just relying on final test results.
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