TechniKrom, Inc.

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TechniKrom, Inc. has announced a new line of Bioprocess LC system upgrades.  It is now possible to take any existing chromatography skid and upgrade it using TechniKrom's patent pending Adaptive PAT™ technology.
 
The upgraded system will be in full compliance with 21 CFR part 11 and include full IQ/OQ validation as well as GAMP-4 software validation.  It will have the ability to adaptively monitor, correct and create incoming isocratic mobile phases to within 0.1% reproducible accuracy. It will also be able to achieve +/-0.1% mobile phase blends (isocratic, step and linear gradients) using buffer concentrates and in-line dilution.
 
"Many companies have large installed bases of LC system and buffer tank farms.  The equipment is functional and well validated, but does not address the latest FDA initiatives to achieve innate product quality through reduced process variability rather than in-process QC.  It is hard to justify discarding a large install base, which represents a major investment" explains Lou Bellafiore, President and Chief Scientific Officer of TechniKrom.  "The need for improved accuracy and reproducibility to reduce process variability is well recognized in the industry, especially with the adoption of Manufacturing Science 6-Sigma which highlight the rapid ROI thus available.  Now, we can upgrade existing equipment and dramatically reduce manufacturing costs with improved process yields and true automation, as well as eliminating the risk for product loss due to mobile phase errors.  The investment in an upgrade can often be recovered in one manufacturing run. In addition, if the software is a few years old, it is unlikely to be in sufficient compliance with 21 CFR Part 11 or GAMP-4 guidelines. We have dedicated significant resources to bring our latest process control software and hardware to the highest levels of performance, validation, and ease of use from lab to commercial scale environments. ."
 
The upgrade modules are based on the same sanitary cGMP platform and patent pending technology available on our Bioprocess integrated system skids.  They can be adapted to feed and control equipment from all major suppliers as well as customer designed equipment made by fabrication shops.

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