Avoiding common pitfalls during tech transfer and process scale-up

One of the most make or break points in the product development cycle is the process of completing technology transfer from one site or entity to another.  This is true whether it is scale up from the R&D lab to the industrial plant or moving a process from one CMO to another due to performance or cost concerns.  This is the point where things can go wrong and all the hard work developing a robust dosage form and precise repeatable methods can come undone when scaled up to industrial batches or moved to an inexperienced CMO.   This can then have the knock-on effect of lengthy delays and cost overruns.

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.

One trap that many companies fall into is poor knowledge sharing and poor communication, often there can be tribal knowledge about the process learned during R&D or at a previous CMO which is not passed on. Thus, the process parameter or IPC that was known to be critical at the earlier stage is not carried forward and the new team loose months troubleshooting what was already well understood by the initial team.   It is no surprise therefore that teamwork and knowledge sharing are very important to a successful transfer.  

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.

Orion Consulting collectively have several decades of experience in the effective development, scale up and optimisation of industrial pharmaceutical processes and in process qualification to achieve consistency and state of the art six sigma processes.  If you are facing a challenging transfer project and you need an expert to guide and oversee your project please get in touch with us.
info@orionconsulting.ie 
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