On 12April2017, I had a call with Bartlomiej Czubek of Mabion to review our recommendations for the PK Validation they are preforming for MabionCD20/Mabthera in NHL serum on the gyros platform. Barlomiej was sent a word document with recommendation on how to prepare the Calibrators and QCs and an Excel document that contained all the necessary tables for a complete validation. During the call, I answered Bartlomiej’s question in regards to the word document, the excel file, and the previous validation they performed for MabionCD20/Mabthera in RA serum.

1) It was agreed that pooled sera would be used to prepare the QCs. The QCs would be prepared in 100% NHL Serum and be stored at -20 C.
2) Stability will only be assessed at -20 C because that is how they have arranged for their samples to be shipped and stored.
3) …show more content…
Mabion seemed concerned with volume of pooled serum that they would need. They seemed hesitant to make small aliquots.
5) Due to the software used by Mabion, the calibrator curve will contain anchors calibrators. The LLOQ and ULOQ QCs will have a calibrator equivalent.
6) Interference by Hemolysis and Lipemia will be assessed.
7) Specificity will be assessed with recombinant CD20.
8) Mabion indicated that the serum samples from patients contained debris, they have been centrifuging them prior to preforming the MRD. I recommended handling the Cals and QCs the same way as the samples are being handled. I recommended setting the Calibrators, QCs, and samples in a 96 well plate, centrifuge the plate, and then transfer to a new plate prior to the MRD and loading onto the Gyros