Reducing Risk of Failure in Technology Transfer

Technology transfer hosts a great deal of risk for the transferring lab embodied by delays associated with failures. Most of these failures may be mitigated by simple strategies including but not limited to restriction of transfers to labs with congruent or very similar equipment, processes that reflect those of the transferring lab and SOPs from the transferring lab that are precise and detail laden so as to limit the interpretation and execution of the method by the receiving lab.

The request for proposals sent to prospective receiving labs should have sufficient detail to limit responses only to those labs which have the exactly specified equipment. However, time and scheduling constraints may give other receiving labs some latitude as long as most of the parameters are unchanged or acceptable work arounds using alternative equipment are provided to the transferring lab. Indeed if the scheduling and timing of a receiving lab are attractive enough, larger transferring labs will purchase duplicate equipment for the receiving lab, even allowing for installation and validation of new equipment.

Suitable work arounds may include confirmation of maxima and minima of spectral peaks in reference materials and products, tolerances and other criteria for reference materials for moisture content, metal content, retention times, relative peak areas for LC techniques, and demonstration of precursor and product peaks in LC-MS.

SOPs should be written with clarity regarding the operational status of all settings, obviously parameters such as flow rate, temperature, minimum and maximum pressure should be mirrored, even aspects of tube length, internal diameter and material should be detailed.

In addition to instrument parameters, the SOPs must contain sufficient detailed instructions on the preparation of mobile phase, buffers, sample parameters. In years as lab director, manager or Auditor of GMP, GLP and GCP analytical and bioanalytical services I almost always saw these prepared in much the same way. First liquid material was added to a "to contain(TC)" mixing cylinder, next solids were added as needed and mixed, with additional liquids added to the mixing cylinder using "to deliver(TD)" cylinders. The cylinder was then capped and mixed by inversion. No additional material was added or removed to account for contraction or expansion of the mix, and there were instruction not to use the material until the temperature of the mixture was at ambient. I have seen descriptions to add volumes to a suitable container. That's it, all the direction given. The explanation for the simplistic direction? The labs know how to prepare a solution, buffer, etc.

Two other examples 1) Add phosphate, which? Most often it is no anywhere more precisely described. Is it Na, K, NH4, Li and is it mono, di or tri? 2) Sonicate or vortex for 10 seconds. If we are trying to dissolve material would it not be more appropriate to indicate an endpoint such as, continue until solubilized. Both processes require some indication of power and additionally, for sonication, an indication of whether a bath, cup horn or probe is used.

By adding detail the possibilities of failure in transfer are not eliminated but the opportunities for failure should be reduced.