Mycoplasma Clearance and Risk Analysis in a Model Bioprocess

1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and

1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and

1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and

1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and

1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and

2Division of Viral Products/Office of Vaccine Research and Review/Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903

2Division of Viral Products/Office of Vaccine Research and Review/Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903

1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and