Optimizing design transfer in autoinjector development
In the August issue of Pharmaceutical Manufacturing and Packing Sourcer (PMPS), SHL Medical’s Director of Account Management, Americas, Taras Seniuch, and Director of Process Development, Dr. Amy Hartl, discuss the importance of design transfer in the development of combination product autoinjectors.
Leveraging their years of experience and intimate knowledge of the industry, the authors discuss several critical factors that are vital for a successful design transfer. They point out that for bio/pharmaceutical companies, mastering all design transfer factors hinge on how they approach final assembly − the moment where the primary container and device components are assembled into a combination product autoinjector.
Here, Hartl and Seniuch discuss several options that a combination product developer may choose when conducting final assembly: internal infrastructure, external contract manufacturing organizations (CMO), and end-to-end solution providers. The article further elaborates the pros and cons of the three options.
The authors conclude that despite the different strengths each option provides, a fully equipped end-to-end solution provider not only offers a seamless experience for drug developers, but also serves as a powerful example of how to effectively execute design transfer.
To learn more on SHL’s integrated services as an end-to-end provider, check out Hartl and Seniuch’s webinar on design transfer.
