Commercial specifications for a new biotherapeutic product are critical component of the product's overall control strategy that ensures safety and efficacy. This paper describes strategies setting commercial as proposed by consortium industry development scientists. The some attributes guided compendia regulatory guidance. For other quality (PQAs), knowledge understanding attribute criticality...

Several oxidase reagents and commercial products were evaluated as to their efficacy in detecting oxidase activity in species of the genus Pasteurella. Recommendations are made concerning the reagent of choice for determining oxidase activity in the genus Pasteurella. Recommendations are made also concerning the use of commercial products and their efficacy in detecting oxidase activity in this...

Government policies on the acquisition of software-intensive systems have recently undergone a significant shift in emphasis toward the use of existing commercial products. Some Requests for Proposals (RFPs) now include a mandate concerning the amount of COTS (commercial off-the-shelf) products that must be included. This interest in COTS products is based on a number of factors, not least of w...

Government policies on the acquisition of software-intensive systems have recently undergone a significant shift in emphasis toward the use of existing commercial products. Some Requests for Proposals (RFPs) now include a mandate concerning the amount of COTS (commercial off-the-shelf) products that must be included. This interest in COTS products is based on a number of factors, not least of w...

Actaea racemosa (black cohosh) has a history of traditional use in the treatment of general gynecological problems. However, the plant is known to be vulnerable to adulteration with other cohosh species. This study evaluated the use of shortwave infrared hyperspectral imaging (SWIR-HSI) in tandem with chemometric data analysis as a fast alternative method for the discrimination of four cohosh s...

Products containing probiotic bacteria are gaining popularity, increasing the importance of their accurate speciation. Unfortunately, studies have suggested that improper labeling of probiotic species is common in commercial products. Species identification of a bank of commercial probiotic strains was attempted using partial 16S rDNA sequencing, carbohydrate fermentation analysis, and cellular...