(310c) Scale-up Considerations for a Continuous Process with QbD in a Manufacturing Setting

A minimum of 150 words is required for the abstract text, and no more than 1500 words may be submitted. Each abstract is allowed to include up to 20 figures.

As part of a new process API introduction we undertake an equipment comparability study to justify equipment selection scale up decisions. This part of the technical transfer process requires that the knowledge developed at smaller scales is understood at the larger scale, in particular that process parameters, the basis of safety and operability issues are adequately considered for each unit operation and risks identified and controlled.

This talk will outline the issues arising when applying this procedure to continuous processes at manufacturing scale at Lilly's Kinsale, Ireland facility, taking QbD principles into account and translating these to a real manufacturing plant.

This talk will outline the issues arising when applying this procedure to continuous processes at manufacturing scale at Lilly's Kinsale, Ireland facility, taking QbD principles into account and translating these to a real manufacturing plant.