Ready-to-use Quantitative Microorganisms for Quality Control Testing

Ready-to-use quantified microbial standards are of significant value for improving end-user workflows and turnaround times in compendial release assays used in the manufacture of biopharmaceutical products and cosmetics. Quantitative preparations of microbial controls are traditionally produced from the dilution of saturated growth culture; however, such techniques demand significant efforts to obtain the desired concentration. Traditional techniques also require revalidation of the cultures at a defined interval to ensure compliance to prescribed standards. While multiple companies have quantitative microbial products on the market that are based on microbial materials sourced from ATCC, they either require longer and more involved assay preparation time or require lower storage temperature (-10°C to -20°C). In order to satisfy the need for quantitative compendial controls that deliver a fast turnaround time with minimal handling, we have developed our best-in-class microbial quality control strains in a novel single-use, ready-to-use, discretely quantitative pellet format. These quantitative controls are directly from a USP-cited strain source-of-origin and demonstrate consistent lot-to-lot quantitation, immediate rehydration at room temperature, and stable storage at refrigeration temperature  (2-8°C).