Common tech transfers challenges
This falls into two categories. One has to do with the equipment challenges and the other would be related to materials. Regarding materials, as we become a more globalized pharmaceutical industry, you may find the excipients in the formulation are subtly different from region to region. An excipient that meets the USP standard in the US, might not meet the criteria in Europe or in Japan, and that may affect release profiles.
And with respect to the API, the particle size distribution of the API on a small batch is totally different than that of commercial quantities. As processes become more automated on the larger scale batches, you may end up with a completely different form of the API that may affect the overall release of the product.
Problems can also arise with equipment. I experienced a product being developed in one region using a gear pump, which is a metered delivery system. When the product was made in another region, a piston pump was used, which gives a varied delivery. Batch records indicated what the pumping rate would be but didn’t specify the type of pump to be used. Make sure the information is there so that the product and the process can be reproduced.
One final thought about technology transfers: Make sure that everybody understands the analytical methods, that people set up the analytical equipment the same way, that stock solutions have similar expiration dates, and that equipment is similarly calibrated. If there’s a discrepancy in results, send an analyst from the site transferring the technology to the site receiving the technology to identify if it’s an operator, equipment, or method issue.
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