Pre-validated calculations in AutoloMATE®


In the ATMP manufacturing process, there are a lot of minor sub-processes that slow things down and introduce potential errors. One category of such sub-processes is calculations; from simple ones like calculating media volumes or cell concentrations, to the more complex such as dosage and regimen calculations. These are required, time consuming, and error prone processes that are commonly performed by a human operator using pen, paper, and calculator.

AutoloMATE eBMR provides a solution to this problem, with pre-configured and pre-validated automated calculation functionality, speeding up manufacturing, improving consistency of record, and eliminating a significant source of human error from the recording process.

That automating calculations has potential for speeding up the manufacturing process should be fairly obvious, especially where more complex and / or multi-step calculations are concerned. We have worked on cases where entire pages of CAR-T paper BMRs have been fully automated, reproducing every value required by the process without requiring any input from the operator apart from sanity checks and actually putting the values into use for manufacturing. These represent significant gains in efficiency, even just from not having to write down all the numbers!

As the calculations are all pre-configured, we can also guarantee consistency of record in a way that a paper BMR cannot. And as all inputs and changes are tracked and logged, AutoloMATE eBMR provides unprecedented transparency and a record you can truly trust.

It is said that to err is human, and experience will tell us that this is true. Computers, on the other hand, do exactly as they are told in precisely the same way again and again, without error. Our pre-configured calculations are tested and validated through the CSV process, guaranteeing correctness and precision to a level no human can, removing a stressor for the operator and ultimately improving the safety of the product.

In addition, our calculations can be fully displayed, and their component values tracked, thus providing complete transparency and traceability for all operations.

Beyond the relatively simple arithmetic you see in the example above, our calculations can perform logical and conditional operations – as well as other, more complex mathematical operations – which can also be used to automate, to some degree, conditional path selection in the manufacturing process.

For example, in calculating the volume of medium to add to a solution in order to get the cell concentration to an expected value, a different calculation may be needed depending on the current cell concentration. A single conditional calculation can perform this task in AutoloMATE eBMR, including deciding whether dilution or concentration is required and guiding the operator through the appropriate process.