Integrated bioanalysis process allows users to put cryogenic vials with a non-volumetric raw plasma sample into the system and collect, after an uninterrupted run, a complete data file
Spark Holland has developed a fully integrated bioanalysis process, allowing users to put cryogenic vials with a non-volumetric raw plasma sample into the system and collect, after an uninterrupted run, a data file containing all information, 21CFR-11 compliant.
The bioanalysis laboratory experiences increasing pressure to finish more studies in less time.
In order to increase the sample throughput, many pharmaceutical companies invest more money in LC/MS equipment.
In reality however most labs do not use these instruments to their fullest capacity and adding new systems only shifts the bottleneck elsewhere in the workflow.
As Rob Castien, Spark Holland president puts it: "we see 25,000 samples analysed per MS, per year as quite feasible.
"That is 100 samples or one microtiterplate per workday.
"The reason most labs don't come close is that they believe adding equipment is going help them.
"We have thoroughly analysed the full lab workflow and find, just as an example, often unforeseen time required for method development puts the project deadline under pressure.
"Had they used a more efficient method development protocol, the problem would not exist.
"Likewise did we integrate sample prep with LC/MS resulting in far less sample manipulation steps and an electronic result file that includes the sample prep method besides the LC/MS method.
"In all, the vial-to-file process dramatically shortens the entire bioanalytical workflow.
"We are currently working with some labs that use our Symbiosis Pharma system and already learned of projected six figure savings on an annual basis.
"We are very excited about being able to offer the industry such a leap forward in Bioanalysis.
