Burkholderia cepacia complex (BCC) species can cause life-threatening infections in susceptible individuals. The presence of these opportunistic pathogens has resulted in recalls of both sterile and nonsterile pharmaceutical products. In a review of Food and Drug Administration (FDA) recalls (e.g., Enforcement Reports) involving 642 microbiologic contaminations between 2004 and 2011, found that most recalls involved sterile products, and of these, medical devices accounted for the majority. The FDA is reminding drug manufacturers to use appropriate acceptance criteria (e.g., United States Pharmacopeia (USP) Chapter <60> Microbiological examination of non-sterile products: tests for Burkholderia cepacia complex) to ensure that drug ingredients, pharmaceutical water, and finished drug products conform to appropriate quality standards. However it should be noted that BCC may not be detected by USP culture methods using Trypticase Soy Agar (TSA) or Trypticase Soy Broth (TSB) cultured at 30–35 °C for 3–5 days. In this publication as well as previous studies in our laboratory, that we reported that the use of oligotrophic medium (1/10 × TSA, 1/10 × TSB, Reasoner’s 2nd Agar (R2A) or Reasoner’s 2nd Broth (R2AB)) allowed for improved recovery of BCC organisms present in distilled water and antiseptics samples.
Research Biologist, Division of Microbiology, FDA/National Center for Toxicological Research, Jefferson, AR.
Research Associate, The Biotechnology Center for Agriculture and the Environment. Rutgers, The State University of New Jersey, New Brunswick, NJ.
Hanyang University, Seoul, Korea; Major, Microbiology; Ph.D.
Current studies are collaborative projects with Center for Drug Evaluation and Research (CDER)/US FDA “Exploring strategies for resuscitation and enrichment of Burkholderia cepacia complex (BCC) strains in pharmaceutical products.” CDC has requested FDA to issue a rule or policy that establishes BCC as an objectionable organism in pharmaceuticals, and United States Pharmacopeia (USP) has revisited the concept of including BCC in its chapters. The objectives of our research are to 1) develop a resuscitative step and enrichment technique for BCC recovery and 2) develop methodology to detect the BCC and its 22 related genomovars.