Technical due diligence on new injector for a high-profile drug product

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.

Project achievements

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.

A high-value partnership

Joe Griffiths, Head of Mechanical Engineering and Design at 42T, says, "Working closely with the client and their development partner, we used a combination of theoretical analysis and pragmatic testing to identify and quantify the remaining technical risks in the design. 

Our independent analysis was invaluable in informing future development decisions, giving our client the confidence to continue commercialising the product.”

Find out more - contact our Director of Healthcare, Craig Townsend.

craig.townsend@42T.com | +44 (0)1480 309461 | LinkedIn: Craig