Why laboratory success is only part of the picture
Laboratory batches are made under conditions that are easy to control. As batch size and equipment change, process variables that had little effect at small scale can begin to influence product quality.
Understanding process variables
Identifying which variables matter, and how sensitive the product is to them, is central to a smooth transition. This understanding is built progressively through development-scale work rather than discovered at commercial scale.
Scale-up is easier when the process is understood before it is enlarged.
Preparing for technology transfer
Clear documentation of the formulation rationale, process parameters and analytical methods supports a more structured transfer to larger-scale manufacturing, whether in-house or with a partner.
- Process understanding at development scale
- Documented rationale for key parameters
- Analytical methods ready to travel with the process
