New Integrated Bioassay Software Simplifies Calculating Accurate Antibiotic and Vaccine Potencies

Synbiosis is delighted to announce that UNISTAT bioassay analysis software has been integrated for use with ProtoCOL 3 colony counting and inhibition zone measuring system. UNISTAT’s Analysis of Bioassays module, available from Synbiosis, will allow scientists a quick, easy method of analysing their ProtoCOL 3 data to generate accurate antibiotic and vaccine potency results.

With just one click of the ProtoCOL 3 system, microbiologists can export inhibition zone measurement and colony count data directly to UNISTAT. The UNISTAT software supports calculations including Parallel Line Method and Slope Ratio Method, to produce potencies with confidence limits and analysis of variance compliant with United States Pharmacopoeia and European Pharmacopoeia. The software also uses powerful tools to detect, omit or replace outliers.

The UNISTAT software generates results in graphs and tables, thus saving time and preventing transcribing errors when transferring data. The module also offers tools to produce publication quality reports that will comply with 21 CFR Part 11 and Synbiosis can supply documentation to allow the UNISTAT software to be integrated with ProtoCOL 3 in a Good Manufacturing Practice (GMP) compliant environment.

Dr Mehmet Toker, CEO of Unistat stated: “We wanted to develop an interface for UNISTAT software for direct use with the ProtoCOL 3 system because we have in the past collaborated with a top ten pharma to produce a specific custom solution so we know there is a demand for this type of application. There will be many major pharmaceutical and biotech companies that would benefit from the multi-purpose UNISTAT bioassay module and the interface we have developed working with Synbiosis and are delighted to be offering this excellent product via Synbiosis and its worldwide distribution network.”

“UNISTAT bioassay software is a gold standard for statistical analysis in many pharma companies,” explained Kate George, Senior Divisional Manager at Synbiosis. “UNISTAT experts have been working with our software developers for the past year to enable seamless data transfer into a format UNISTAT can process quickly and easily. Now we’re confident that the integrated ProtoCOL 3 and UNISTAT package we’re supplying is the perfect combination for antibiotic or vaccine manufacturing facilities that need to increase testing accuracy, as well as securely store their results for on-demand review by any major regulatory authority.”