What inspired this Wish List Request?
A request from Moderna for Random batch stability study support in JMP similar to what is done in Minitab (https://support.minitab.com/en-us/minitab/21/help-and-how-to/statistical-modeling/regression/how-to/stability-study/before-you-start/example-with-a-random-batch-factor/)
Please describe the new or improved feature or solution you would like to see.
JMP doesn't currently have a method to directly support a Random Batch Stability study. Minitab is currently using a simpler Linear Mixed Model approach with an offset to account for the quantile component (https://support.minitab.com/en-us/minitab/21/help-and-how-to/statistical-modeling/regression/how-to/stability-study/methods-and-formulas/shelf-life-for-random-batches/). A better answer with broader applicability would be to provide a Quantile Mixed Model capability in GenReg.
What would the value be to you and/or other users if this new feature is provided?
Larger Pharma manufacturers have started asking about this capability in recent months. It seems to be seen as a superior method to the simpler single batch implementation we provide in the degradation.
Is this an external customer request?
Yes, Moderna and Takeda have both asked about this capability in the past 6 months.
Is there a competitive software package that has this feature or solution that we should be aware of?
Yes, Minitab provides a LMM based random batch analysis. Implementing a Quantile MM would be a more general solution.
Will this impact a renewal, expansion, or adoption at a customer, and does this put an account at risk if we do not address this?
The number of requests in the past year make me think that we will lose ground to Minitab on this issue if we don't address this in a timely fashion.
