The two companies developed and validated strain-level identification assays in probiotic testing, which they said would lead the way for industry-wide product integrity and label accuracy.
Citing a 2017 review paper published in the Journal of Pediatric Gastroenterology and Nutrition (Vol. 65, No. 1, pp. 117–124), the companies said the need for strain-specific testing was clear, with challenges including incorrect taxonomy, missing species and unlabeled species.
“These findings emphasize the necessity of reliable methods to determine the taxonomy of microbial populations in probiotic products,” said Wesley Morovic, scientist in the Genomics & Microbiome Science group at DuPont Nutrition & Health.
“However, because strain identification has not historically been required, little investment has been made to support the industry in doing so. DuPont is one of few manufacturers to share its genetic identification methods with customers and the public.”
PCR
DuPont has developed a PCR (polymerase chain reaction)-based solution that targets the individual genomic differences between bacterial strains to rapidly identify specific DuPont probiotics. The testing solution works flexibly in concentrated ingredients or blended with other probiotics and excipients, offering the ability to test at several points in the manufacturing process.
The company has validated the method for scores of commercial multi-species products, with findings made available via a paper published in Frontiers in Microbiology (W. Morovic et al. doi: 10.3389/fmicb.2016.01747).
DuPont has since continued work on its PCR method and worked with Eurofins to develop PCR genotyping assays to identify probiotics at the strain level in both raw materials and finished products.
“Many manufacturers understand that verifying raw materials and identifying finished products is as important as quantifying potency, for both label compliance and manufacturer confidence,” explained Mehgan Styke, business development manager at Eurofins.
“But until now, the tools for specific and accurate identification were either inaccessible or had yet to be developed; adding to the challenge are the nuances of probiotic products. With DuPont’s strain assays, Eurofins has become the first third-party laboratory to support identification to strain level, completing our portfolio of accurate testing for full label verification of potency, stability and identification.”
Michael Drozd, president of Eurofins AgBio, added: “These methods are at a cost and efficiency in line with the current less accurate and less specific methods. We are excited to leverage the collective knowledge of DuPont and Eurofins BioDiagnostics to bring the industry to a higher level of transparency.”