The pharma industry practice of 'process fit', which allows the manufacture of most products by re-using existing physical assets, raises the perennial question of whether a given process running well at Lab A or Site B can also be run well at Site C. Anyone who cooks or bakes even occasionally in their own kitchen will know that equipment dimensions and operating conditions affect product quality (and cycle time) and the same is true at manufacturing scale.
This problem used to be handled with a 'boots on the ground' approach, where extensive air travel and time on site allowed detailed oversight, some costly experimentation and tweaks locally before manufacturing. With a large portion of manufacturing now contracted out to CDMOs, tech transfer remains challenging unless you have the right tools.
Working with over 100 companies engaged in the development and manufacture of pharmaceuticals, we get an up-close look at the issues, challenges and opportunities around tech transfer. Probably the single biggest factor that makes our tools indispensable to accelerate this work is the Dynochem Vessel Database.
Users like to achieve 'equivalence' between equipment performance at the transferring and receiving sites. Equivalence may sound simple but the different scaling laws that apply to mixing, heat transfer, solids suspension and mass transfer make this complex; and that's before even considering meso-mixing and micromixing. Apparently inconsequential differences that are easy to miss, such as materials of construction, heat transfer fluids, impeller types, sizes and positions and even feed locations can have a large impact on performance at the receiving site.
The likelihood of Right First Time tech transfer increases dramatically with a sufficiently detailed Vessel Database that accurately stores the configuration of site equipment. Link that with the recipe of the target process, our equipment calculators and peer-reviewed physical properties from our Materials System and you can perform Digital Tech Transfer quickly and accurately without leaving your desk.
If you haven't already created the Vessel Database for your site or wider organization, you can start here from our template. It's an ideal project for a young engineer and once done correctly, saves time for everyone on the team.
|Selection of 'impeller' types in the Dynochem Vessel Database; users may also add custom impellers and internals