The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud.

The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis.

A novel broth medium for enhanced growth of Francisella tularensis.

Unlabelled: Francisella tularensis is a fastidious organism that requires a lengthy incubation time in liquid growth media for detection. The objective of this study was to develop a medium formulation using readily available supplements that enhanced early growth of F. tularensis.

European Bioanalysis Forum: recommendation for dealing with internal standard variability.

Adequate monitoring of internal standard (IS) response across an analytical run and identification of anomalies is now a common expectation. However, the means to conduct this assessment in an appropriate manner is unclear and differs widely between laboratories. A European Bioanalysis Forum (EBF) topic team was formed to survey current practices within European Bioanalysis Forum member companies and to recommend a best practice approach for dealing with IS response variability.

Disinfection of Bacillus spores with acidified nitrite.

Disinfecting water generated from a bioterrorism contamination event will require large amounts of disinfectant since the volume of water flushed from a drinking water distribution system or wash water collected from a contaminated outdoor area can accumulate quickly. Commonly used disinfectants may be unavailable in the necessary amounts, so evaluation of alternative disinfectants is needed. This study focuses on disinfection of Bacillus spores in water using acidified nitrite.