Thursday 2nd April 2009
Synbiosis announces its ProtoCOL automatic zone measuring system has new features, designed to improve the speed of analysing SRD plates, ensuring flu vaccines can be manufactured more rapidly.
The ProtoCOL can generate results from a 16-zone SRD (Single Radial Immunodiffusion) plate of flu vaccines in minutes. This means scientists can analyse 10 SRD plates in the time it would take to manually analyse one. The system’s software supports 21CFR Part 11 and includes a gantry control, allowing automatic imaging of larger SRD plates when required. These innovative features make ProtoCOL ideal for increasing productivity in any GMP vaccine production facility.
The ProtoCOL’s computer controlled, high-resolution CCD camera captures precise zone images and its new software automatically assesses not just two points from around the circular zone, as would be performed manually but simultaneously analyses multiple points. The software then rapidly calculates a precise average diameter measurement to provide an accurate indication of vaccine potency.
The highly reproducible results are automatically transferred into Excel or to a LIMS system for storage or statistical analysis where a vaccine’s batch number or name can be entered into the ProtoCOL software. An image library is also created alongside, permitting staff to see an SRD plate if there is a query after it is disposed of. These files ensure producing raw data and professional reports for each flu vaccine, as and when required by regulatory authorities, is a simple task.
Martin Smith of Synbiosis commented: “The market for flu vaccines is very competitive and there is only a short time when there is a large product demand. Therefore, pharma and biotech companies that can have their vaccines available first, have a clear advantage. Using our advanced ProtoCOL system will help achieve this because automating analysis of SRD plates means a vaccine’s potency can be determined in minutes, rather than hours, thus reducing manufacturing timelines.”
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