Food Safety Exam Phrasing for Food Service Employees.

In many jurisdictions, foodservice workers are required to obtain food handler certification via written examination before being able to work. This study investigated the effect of the readability, or the ease in which one can read and comprehend written text, of food handler exam questions on exam performance. It was hypothesized that the reduction in cognitive load by improving the readability of exam questions would lead to improved scores. Participants received training in personal hygiene and basic food safety and were tested on their knowledge using questions that were worded using the traditional phrasing and updated phrasing that has improved readability. The results indicate that improved readability had a significant difference in the personal hygiene section but not on the basic food safety section. These results are due, in part, to the types of cognitive load (intrinsic vs. extraneous) that are required to solve different types of problems.

Analytical assessment of clonal derivation of eukaryotic/CHO cell populations.

Cell populations that are exclusively composed by descendants from a defined single parental progenitor are referred to as "monoclonal", "clonal" or more correctly as "clonally derived cell population". Clonal derivation of cell lines used in the manufacturing of recombinant biologics is a regulatory requirement that aims to ensure a robust process and consistent quality throughout the life cycle of a product. Clonal derivation of cell lines is usually ensured by the process (e.g. two subsequent rounds of limiting dilution). Here we present an approach to analytically assess the probability of clonal derivation of existing cell populations. Using target locus amplification (TLA) followed by next generation sequencing (NGS), unique genetic features can be identified, for example the integration site of the plasmid in the host cell genome or plasmid-plasmid junctions of the plasmids used for expression of recombinant biologics. Whereas a direct assessment of clonal derivation using TLA/NGS data is challenging due to limitations in specificity, confirmed clonally derived populations generated from the cell line population can be analyzed by qPCR for the presence of the unique genetic features identified by TLA/NGS. In the present study, a statistical analysis allowed the demonstration that two independently generated CHO cell lines were clonally derived with an upper 95% confidence interval limit of a potentially present contaminating population of 1.3%.

Process and Method Variability Modeling to Achieve QbD Targets.

A statistical modeling tool is presented that enables real-time viewing of how changes in method, process, and stability variability/bias impact product acceptance rate. The tool can be used to set and justify specifications. As needed, additional sources of variability/bias can be added to further optimize the tool's prediction power. The tool can be used to assess each manufacturing run to ensure the process is in control. Aberrant results can then be investigated to see what source of variability/bias may have changed. To enable continuous improvement, the impact of new processes, methods, or technologies can also be addressed and such changes justified.