Our pharmaceutical client wanted to license a delivery device for a key drug product that used a new automatic needle protection mechanism. Our high-profile client had identified a candidate that, on paper, met their requirements.
Before committing to partner with the developer, they wanted a better understanding of its suitability and risks involved in adoption, and so they approached 42T.
What we did
Based on analysis we had previously done on one of the client’s auto-injectors, 42T was the client’s first port of call for an independent technical review and FMEA of the design.
Our activities included modelling the effects of manufacturing tolerances and environmental conditions, and assessing suitability for scaled-up manufacturing processes.
We also identified key areas of risk where further data should be gathered or small design changes were recommended.
Our input enabled both parties to embark on a high-value partnership with better confidence of success.
Results for our client
Our independent analysis was invaluable in informing future development decisions, giving our client the confidence to continue commercialising the product.
Our client was able to license a new delivery device design with a detailed understanding of the technical risks involved in development and launch for their drug product.
We also mitigated the risk of large financial losses and product launch delays by early identification of outstanding technical risks and design improvements.
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