PPD Review: Bioanalysis of a protein therapeutic in support of a proof of concept (POC) study

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Wilmington, NC 28401-3331
United States
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Bioanalysis of a protein therapeutic in support of a proof of concept (POC) study

Overall: 2 stars

Date: July 9, 2014

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Service Description

PPD was contracted to conduct ligand binging and immunoecity assays using previously validated assays to support a first-in-man POC trial. Samples were collected for this study over an approximately 18 month period, requiring periodic sample analysis. Both active and comparator arms of the trial were analyzed. Maintenance of study masking was important. Fast data turnaround time at the end of study was expected.

What Went Well

Study masking was maintained. Periodic inventory review of expected versus received samples were prepared. Analysis was conducted periodically as large shipments of samples were received and the data turnaround time met expectations at the end of study.

What Could Be Improved

We had an issue during the study were new lots of QC samples for the LBA assay were failing. The lab seemed to flounder in determining a root cause of the issue until a subject matter expert was sent to help with the data assessment. Resolution led to a partial validation of the method, which was rapidly conducted, but not reported promptly. In addition, following completion of the study, several clinical sample discrepancies were discovered between the internal clincial and the bioanalytical groups. A few of the discrepancies had been discovered during sample reconcilliation at PPD, but were not brougt to our attention until the report writing phase. It took quite some time for the internal documentation to be provided to PPD for the report revisions to take place. The project manager was prompt in his response, but the writing and QA groups always seem to slow everything down. Also, the report writing group is resistant to customizing report templates to meet the needs of the client.

Lessons Learned from the Experience

We learned the size and experience does not always translate into speed or quality. In fact, it seems to have a negative impact on speed for most everything including access to analysis slots, report writing and QA, and even SOW generation and approval. One of the critical issues that prevents out of the box thinking is the very clear separation between method development and production groups. When production encounters an issue, there is the tendency to try to resolve the problem there first without bringing in the MD scientists. Eventually, they were consulted, but not without a loss of time.