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.
After a conversation with Mike, what Minitab is doing is more of a tolerance interval approach, which has advantages and disadvantages. A full mixed model quantile regression is perhaps the best solution. I've created a Jira for this in hopes of including in v19. https://jmpdiscovery.atlassian.net/browse/JMP-20028
Update re: Random Batch Shelf Life Stability Analysis Add-in - I needed a solution for Moderna urgently and missed the dev window for 18.0 (would love to see it in 18.2
). The add-in was developed as a stop gap to answer the customer concern (high priority) and allow development time to decide if/how they wanted to include in product. If development includes this wish I can pull the add-in and edit the blog article that covers the math. The stop gap was to protect against a JMP Pro downgrade at Moderna and general loss of business to Mintab.
Thanks @MikeD_Anderson ! I added the add-in link to the Jira for reference.