Technology Transfer – Memo 1 what is Technology Transfer

Technology Transfer is essentially the name given to those activities concerned with the moving of a manufacturing process from one place to another within a company such as R&D to pilot plant or one manufacturing line to another, or from one company to another and it can happen for many reasons. Quite often Technology Transfer is associated with process improvements or scale-up or modernisation of the analytical methods as well as with the physical movement of the process itself.

In times past, Technology Transfer was performed by means of handing over a process and Analytical Technology Package (P&A-TP) or similar, usually consisting of a process description, equipment list, Bill of Materials (BOM), and analytical package and then implementing the process described as best able to do so. The end product was then sampled and tested and if the release specifications were met the technology transfer process was considered to be complete (I know that this may be a bit of a simplification, but it describes the general methodology which, although sometime formalised, was often as not more of an informal process in other than the largest companies).

All this changed with the advent of a formalised structure for Process Validation (FDA Process Validation: General Principles and Practices 2011). From this point onwards the role of technology transfer also included the requirement to ensure that the Process Validation requirements were also fully complied with, and formalised and documented. Formalised Technology Transfer became more almost mandatory as a result. In some respects, technology transfer has become a specific element of design and development for pharmaceutical drugs; it’s governed by ICH Q10.

There is still no single definition of technology transfer, with many varieties existing as exampled below:

  • WHO: a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites. [WHO Technical Report Series, No. 961, 2011 Annex 7].
  • FDA: Technology Transfer is the process of transferring skills, knowledge, technologies, and manufacturing methods.
  • ISPE (Novartis Pharmaceuticals Corp. September 10, 2009Presentation): Transfer all the knowledge needed to perform a given (biotech) process from a Transferring Site to a Receiving Site.

However, it is the definition given in ICH Q10 that ties the technology transfer process into the process validation process:

The goal of Technology Transfer activities are to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realisation. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement. [ICH guideline Q10 on pharmaceutical quality system].

This definition means that a more formal technology transfer process is needed in order to ensure that all process validation requirements are met, and perhaps a better general definition could be used:

It should be remembered that Technology Transfer also involves the development and successful transfer of the analytical and microbiological test methods and specifications.

Changes in process scale or materials used can result in process variability, and critical process parameters may need to be optimized, or in worst cases the entire process may need to be redeveloped before a successful Technology Transfer can be performed.

It is sometimes said that the aim of technology transferred is to get to market quickly with the development of a drug and product of the appropriate quality and to do it “right first time, every time”.  My view is that the primary aim of technology transfer should be to ensure that the transferred process can consistently manufacture product commensurate with its efficacy, safety and quality requirements. While speed is good, it should never be at the expense of product quality.