Neetu Raghav1, Seema Parveen1, Simleen Kaur1

  • 1Division of Biological Standards and Quality Control, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, FDA, White Oak, MD, United States.

概括

一种新的Schaedler血 (SBA) 无菌性测试显著减少了生物产品中微生物的检测时间. 这种更快的不育测试方法在7天内取得了结果,而不是标准的14天综合方法.