OptiQual HIV-1 High Positive External Run Control
Monitors upper limit of quantitative assays
The new OptiQual HIV-1 high positive external run control from AcroMetrix, Benicia, Calif, provides a high concentration of HIV-1 for use in monitoring the upper limit of quantitative assays. It contains the noninfectious 8E5 HIV-1 strain to help ensure safety in the lab. Developed to ISO:17511 standards for traceability to the second WHO International Standard for HIV-1 RNA, the whole-virus product controls for the entire PCR process—including extraction—to help labs monitor reagent-lot variation and detect systematic error within the upper regions of assays. It can be stored at -20°C, freeing up valuable deep-freezer space. The product is for research use only—it is not for use in diagnostic procedures.
AcroMetrix
(888) 746-7921
www.acrometrix.com
QMS Amikacin Assay
For therapeutic drug monitoring
Beckman Coulter Inc, Fullerton, Calif, has expanded its therapeutic drug-monitoring test menu to include QMS® Amikacin. The assay measures aminoglycoside concentrations in human serum or plasma to guide and monitor dosing regimens, and to evaluate the toxicity and efficacy of Amikacin, an antibiotic used to treat bacterial infections. Reagents and calibrators are liquid and ready-to-use, which eliminates the need for mixing, hydrating, or pre-diluting reagents before testing. When used in conjunction with a UniCel® or Synchron® clinical system, the assay provides timely TDM results. It is manufactured by Thermo Fisher Scientific and distributed by Beckman Coulter.
Beckman Coulter Inc
(714) 993-8432
www.beckmancoulter.com
Ready Pack System
For sterile drug packaging systems
West Pharmaceutical Services Inc, Lionville, Pa, has introduced the Ready Pack™ system, a packaging solution to help pharmaceutical and biopharmaceutical companies mitigate challenges in identifying low-risk packaging components for small-quantity lab and clinical applications. Customers receive needed documentation for accepting sterile, ready-to-use components into their facility. The system includes VeriSure™ stoppers, Flip-Off® seals, and Ready-to-Fill™ vials, which are also available individually. The stoppers provide a solution for at-risk-mitigation and change-control strategies, while conforming to Quality by Design initiatives. They include a certificate of analysis that identifies the extractables, their specifications, and the quantity of the extractables for each lot of components. Stoppers are manufactured with FluroTec® barrier film, washed by the Westar® ready-to-sterilize process, and sterilized by the Westar ready-to-use process. The features help ensure consistency of components from the early-development phase through commercialization.
West Pharmaceutical Services Inc
(800) 231-3000
www.westthesource.com
